4Q2012EXCEL DMF# 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 STATUS Type SUBMIT DATE I I I I I I I I A I I I I I N I I I I I I I I I I I I N I I I I I I I I II II 9/3/1946 12/26/1946 5/22/1947 10/13/1946 12/12/1946 1/1/1947 12/13/1946 2/11/1947 II II II 6/1/1946 9/1/1947 1/1/1940 8/22/1946 1/1/1940 7/25/1946 11/3/1947 7/30/1946 6/2/1946 3/22/1946 9/12/1946 1/1/1946 II II IV II III II 2/8/1981 11/4/1947 5/8/1943 5/13/1943 6/5/1943 1/1/1940 4/9/1943 6/19/1943 1/1/1950 2/20/1944 2/23/1944 3/12/1944 2/21/1947 1/1/1945 HOLDER HEXCEL CHEMICAL PRODUCTS ROHM AND HAAS CO MONSANTO CHEM CO DIV MONSANTO CO NIACET CORP SUBJECT CPC LETHANE 384 SPECIAL SUCCINYL SULFATHIAZOLE SUCROSE OCTA ACETATE

4Q2012

CALCO CHEM CO DIV AMERICAN CYANAMID N' BUTYRYL SULFANILAMIDE SODIUM-N' BUTYRYL SULFANILAMIDE CO NATIONAL RESEARCH COUNCIL PENICILLIN FRIES BROS INC WF STRAUB & CO EASTMAN CHEMICAL CO NATIONAL RESEARCH COUNCIL HERCULES POWDER CO ROHM AND HAAS CO NATIONAL RESEARCH COUNCIL YEAST PRODS INC NOT AN ASSIGNED NUMBER FLUORDENT INC VETERANS ADMINISTRATION PENICK CORP FRIES BROS INC FLUORIDES STREPTOMYCIN TYROTHRICIN DESOXYEPHEDRINE META HOMO MENTHOL HEXESTROL C-A-P(TM) CELLULOSE ESTER, NF GELATIN & OTHER BLOOD SUBSTITUTES SODIUM CARBOXYMETHYLCELLULOSE HYAMINE X (QUATERNARY AMMONIUM CHLORIDE COMPOUND) BAL IN OIL RIBOFLAVIN, ACETYLATED

ABBOTT LABORATORIES PHARMACEUTICAL THIOURACIL PRODUCTS DIV SMITH KLINE & FRENCH LABS DIV CARBOXYMETHYLCELLULOSE SMITHKLINE BECKMAN CORP MERCK AND CO INC NITROGEN MUSTARDS DEPT OF DEFENSE-ARMY LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO JOHNS HOPKINS HOSPITAL PROTEIN HYDROLYSATES STERILE FILLED PHARMACEUTICAL PREPARATIONS P-ARSENOSOPHENYLBUTYRIC ACID

ABBOTT LABORATORIES PHARMACEUTICAL VITAMIN K, HYKIMONE (ABBOTT) PRODUCTS DIV CINBERG B L MD PROGESTERONE NOT AN ASSIGNED NUMBER BOOTS FLINT INC SUB BOOTS CO USA INC NATIONAL RESEARCH COUNCIL NEW YORK QUININE & CHEMICAL WORKS INC STEPAN CO INC SB PENICK AND CO ORIG AMINO ACIDS SN 13,276; PALUDRINE (CHLORUGUAN); SN 12-837 METOPON B.T.C.(ACTIVE INGRED: BENZALKONIUM CHL) RUTIN

UNIVERSITY OF CHICAGO DEPARTMENT OF CARBOWAX--POLYETHYLENE GLYCOLS & OTHER GLYCOLS MEDICINE NATL INST HLTH CLINCL CTR PHARMACY PALUDRINE PARKE DAVIS & CO ANTIMALARIAL SN 10751

Page 1

4Q2012EXCEL DMF# 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 STATUS Type SUBMIT DATE I I I I I I I I I I I I I I N I I N I I N I I I I I I I I I I N I I I I I I II II 3/22/1951 1/1/1940 6/11/1951 6/27/1951 7/19/1951 7/31/1951 II II 1/1/1950 9/16/1963 1/31/1967 3/5/1951 3/9/1951 1/1/1951 1/1/1940 4/27/1950 1/1/1940 1/20/1950 3/9/1950 9/20/1949 10/17/1949 II II II 4/17/1947 3/7/1947 8/2/1946 6/6/1947 10/21/1947 10/1/1947 10/29/1947 1/16/1947 12/19/1947 2/12/1948 2/9/1948 12/23/1947 3/26/1948 9/10/1963 HOLDER UNIVERSITY OF MINNESOTA GIVAUDAN-DELAWANNA INC US ATOMIC ENERGY COMMISSION DR. KARL JOHN KARNAKY WISC ALUMNI RES FDTN JOHNS HOPKINS HOSPITAL SCHERING CORP SUB SCHERING PLOUGH CORP US PUBLIC HEALTH SERV ICI AMERICAS INC USPHS HOSPITAL BATTELLE MEMORIAL INSTITUTE ENDO PRODS INC LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO ROHM AND HAAS CO NOT AN ASSIGNED NUMBER SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP SCHENLEY LABS INC NOT AN ASSIGNED NUMBER WYETH INC SNYDER AND SNYDER NOT AN ASSIGNED NUMBER HEYDEN CHEM CORP ENDO PRODS INC PENICK CORP FIRMENICH INC ROHM AND HAAS CO AMERICAN CYANAMID CO NATL INST HLTH CLINCL CTR PHARMACY LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO DEPT AGRICULTURE COMMERCIAL SOLVENTS CORP NOT AN ASSIGNED NUMBER UNITED STATES PHARMACOPEIA CHAS PFIZER AND CO INC SB PENICK AND CO ORIG INTERNATL HORMONES INC METAL & THERMIT CORP PACIFIC YEAST PRODUCTS INC ACTH POLYMYXIN CASANTHRANOL AQUEOUS MICROSUSPENSION OF HORMONES DIBUTYL TIN DILAURATE B 12 SSUPPLEMENT (B-MEGAHERIUM) SOLPROTEX (DIGALLOYL TRIOLEATE) RESINS - ION EXCHANGE AMBERLITE IRP 276 (CHOLESTYRAMINE RESIN USP) DIOCTYL SODIUM SULFOSUCCINATE LEVO-ISO-METHADONE GENERAL METHODS OF ASSAY AND CONTROLS STARCH SPONGE DEXTRAN(DWAS DISCN 7.31.51) MADE PAET OF NDA 8008 P.A.S. (PARA-AMINOSALICYLIC ACID & SODIUM PARA-AMINOSALICYLATE ) MANIBEE-C-FORTE ARTISONE ACETATE ANTIHISTAMINE INSOMNIA TREAMENT (MISCELLANEOUS) KELLIN--TOXICITY STUDIES CONTEBEN SUBJECT AMIDONE, DOLPHINE, (4,4-DIPHENYL-6-DIMETHYLAMINO-3-HEPTANONE HCL) DIBENAMINE RADIO ISOTOPES STILBESTROL, INJ. & TABLETS MOHIS CANCER PASTE; ZINC CHLORIDE FIXAIVE THE ADMINISTRATION OF DI-ISOPROPYL FLUOROPHOSPHATE (DFP) TO MAN ANTIHISTAMINICS VIRUS, THERAPEUTIC SERUM, TOXIN ANTITOXIN

4Q2012

SORBITOL, MANITOL, HEXITOL EMULSIF. AGENT-TN: SPAN; TWEENS; ARLACEL ISOMETHADON SELENIUM SULFIDE ENCODOL (DIHYDROHYDROXY CODEINONE) LEDINAC PARENTERAL AMBERLITES IRC-50 & XE 64

Page 2

4Q2012EXCEL DMF# 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 STATUS Type SUBMIT DATE I I A I A I I I I I I I I I I I I I I I I I I N I N A I I I I I I I I I I N I 5/21/1953 II II II IV 6/2/1965 8/26/1952 10/29/1952 9/16/1952 1/1/1940 1/1/1940 2/3/1953 12/16/1952 3/18/1953 5/28/1953 5/29/1953 1/1/1940 II II II IV 9/8/1966 7/16/1951 10/18/1951 8/11/1950 1/31/1952 1/1/1940 1/1/1940 1/1/1940 1/1/1940 2/25/1952 1/1/1940 4/4/1979 3/4/1954 3/25/1952 5/9/1952 6/23/1952 5/19/1952 1/1/1940 9/22/1952 IV 7/30/1951 7/31/1951 3/10/1950 HOLDER PERMUTIT CO SB PENICK AND CO ORIG DOW CHEMICAL CO SCHERING CORPORATION INTERNATIONAL SPECIALTY PRODUCTS MAYO CLINIC DIAMOND SHAMROCK CHEM CORP NATIONAL STARCH & CHEMICAL CORP CHLORAMINT CO TRACER LAB INC NATIONAL RESEARCH COUNCIL HOFFMANN LA ROCHE INC DEPT OF DEFENSE-ARMY AMES CO DIV MILES LABS INC PLAVOLEX PLASDONE POLYVINYL PYRROLIDONE COMMITTEE ON SAFETY OF THERAPEUTIC AGENTS DIPHENYLPYRALINE(THIS DFORMERLY HELD BY NOPCO CHEM. CO) DRYFLO SUBJECT PERMUTIT Z-AMMONIUM; PERMUTIT Z P-POTASSIUM VERABORE--SPECIAL AMORPHOUS ALKALOIDS OF VERARUM VIRIDE METHOCEL HG --HYDROXYPROPYL METHYLCELLULOSE

4Q2012

O-SILVER ANTISEPTIC DISPOSABLE DIAPERS & ANTISEPTIC SURGICAL DRESSING RADIOACTIVE ISOTOPES (CONTAINS MEMO ON) PLASMA EXPANDERS TREAMENT FOR TB PRIMAQUINE N-ACETYL-PARAAMINOPHEMOL PLAVOLEX (PLASMA VOLUME EXPANDER)

ER SQUIBB & SONS PHARMACEUTICAL LABS NYDRAZID WORTHINGTON BIOCHEM CORP AMERICAN CHOLESTEROL PRODUCTS INC A MASCHMEIJER JR INC EI DUPONT DE NEMOURS AND CO NIPA LABORATORIES INC NEPERA CHEM CO MONSANTO CHEM CO DIV MONSANTO CO NOT AN ASSIGNED NUMBER PFIZER AND CO NOT AN ASSIGNED NUMBER BASF CORP PARKE DAVIS & CO GEORGE A BREON CO INC SB PENICK AND CO ORIG CHAS PFIZER AND CO INC NATL INST HLTH CLINCL CTR PHARMACY ROUSSEL CORPORATION DEXTRAN CORP NORDA ESSENTIAL OIL AND CHEM CO INC LLOYD BROS INC SB PENICK AND CO ORIG NOT AN ASSIGNED NUMBER TERRA CHEMICALS INC AEROSIL PLURONICS (L62 F68) L44 PLURONIS POLYOLS GENERAL METHODS OF MANUFACTURE $ CONTROL METHODS ,FACILITIES $ CONTROLS AQUEESTROL STREPTOMYCIN HYDRAZIDE ISONICOTINYL DARAPRIM (PYRIMETHAMINE) CORTISONE ACETATE PLASMA EXPANDERS DICHLOROSAN COBALT NEOMYCIN SULFATE USP LUDOX HYALURONIDASE AMERCHOL ISONICOTINIC ACID HYDROZIDE ALAHON (POLYTHENE RESIN) OTTAFECT AND OTTASEPT COMPOUND 1318 ACTAMER

Page 3

4Q2012EXCEL DMF# 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 STATUS Type SUBMIT DATE I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I II II II II I V II IV II II 6/23/1953 7/3/1953 7/5/1953 8/14/1953 9/11/1953 5/9/1952 9/21/1953 10/23/1953 11/18/1953 11/20/1953 10/20/1953 7/23/1953 1/20/1954 2/9/1954 2/1/1954 2/23/1954 1/27/1954 9/23/1953 1/1/1940 1/25/1954 2/10/1954 9/28/1953 5/20/1954 4/27/1954 5/26/1954 5/25/1954 1/1/1940 10/21/1947 10/6/1941 1/1/1940 7/2/1954 1/17/1977 7/14/1954 9/3/1954 9/2/1954 1/1/1940 9/15/1954 HOLDER CHATTEM CHEMS DIV CHATTANOOGA MEDICINE CO RT VANDERBILT CO SARATOGA TRADING CORP SB PENICK AND CO ORIG SUBJECT DIHYDROXY ALUMINUM-SODIUM CARBONATE VANCIDE 89 (CAPTAN) RAUWOLFIA SERPENTINA PROTAVERARINE

4Q2012

PASADENA RESEARCH LABORATORIES INC HYDROCORTISONE ACETATE ER SQUIBB & SONS H REISMAN CORP NEPERA CHEM CO NORDA ESSENTIAL OIL AND CHEM CO INC SB PENICK AND CO ORIG UNION CARBIDE AND CARBON CORP PFIZER AND CO MEER CORP DOW CORNING CORP WARWICK CHEM CO GENERAL ANILINE AND FILM CORP RK LAROS CO UNION CARBIDE AND CARBON CORP CENTRAL SOYA GIVAUDAN-DELAWANNA INC NATIONAL RESEARCH COUNCIL LIDD DAVID MD AMGER CHEMICALS INC SB PENICK AND CO ORIG DOW CHEMICAL CO MICHIGAN DIV NEPERA CHEM CO RG TAYLOR CO INC SE MASSENGILL CO-ORIG ORGANICHEM CORP BF GOODRICH COMPANY BF GOODRICH COMPANY US ATOMIC ENERGY COMMISSION CENTAUR CALDWELL DIV STERLING DRUG INC 3M PHARMS CHAS PFIZER AND CO INC IOWA STATE COLLEGE THOS LEEMING & CO SUB CHAS PFIZER & COMPANY INC VITAMINE B-12 EPOXYTROPINE TROPATE METHYLBROMIDE COMPOUND NO.1112 HALOSAN PHTHALAMAQUIN VINYLITE VAGH RESIN NEOMYCIN SULFATE CAPS (THIS DCHANGED TO NDA 9-579) RAUWOLFIA SERPENTINA SILICONES WARCO A-266 SODIUM N-LAUROYL SARCOSINATE FRUCTOSE LINDE SILICONE L-45 SOYBEAN STEROL PRODUCTS SUNSCREEN M.E.C. DRUG ADDICTION $ NARCOTICS POLYVINYL PYRROLIDONE DEHYDROACETIC ACID RESERPINE SHORT TERM CHRONIC DIETARY FEEDING OF METHOCEL 2602 TO RAS THONZONIUM BROMIDE A-THYMOXY-A-A-DICHLORACETIC ACID, A(1 METHYL-4-ISOPROPL-3-PHENOXY)-A-A FACILITIES $ CONTROL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. PARACHLORPHENOL MONOSULFIDE MONOBENZYL ETHER OF HYDROQUINONE RADIO ISOTOPES, IODINE 131 AND PHOSPHORUS 32 FACILITIES $ CONTROL VARIOUS RAUWOLFIA SPECIES RESERPINE DIETHYLSTILBESTROL AS A CATTLE FEED ADDITIVE FACILITIES ,CONTROL

Page 4

4Q2012EXCEL DMF# 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 STATUS Type SUBMIT DATE I I I A I I I I I I I I I I I I I I I I I I I I I I I I N I I I I A I I I I II II 10/28/1955 10/13/1955 1/1/1940 1/1/1940 2/29/1952 12/5/1955 12/22/1955 7/24/1956 1/11/1956 I II I IV II II IV II 1/1/1940 6/1/1955 10/1/1954 9/29/1954 4/25/1955 11/3/1954 11/4/1954 11/5/1954 11/9/1954 11/9/1954 1/1/1940 1/11/1955 1/27/1955 1/25/1955 2/1/1955 3/29/1955 2/25/1955 3/10/1958 1/1/1940 7/13/1955 6/15/1955 8/16/1955 8/18/1955 8/18/1955 6/14/1955 8/24/1955 1/1/1940 5/12/1955 HOLDER LLOYD BROS INC NATIONAL RESEARCH COUNCIL LUBRIZOL ADVANCED MATERIALS INC SB PENICK AND CO ORIG SUPRAMAR CHEMS MEER CORP GENERAL ELECTRIC CO MEER CORP CORN PRODS INC BF GOODRICH COMPANY ROUSSEL CORPORATION WORTHINGTON BIOCHEM CORP WEST DISINFECTING CO CF BOEHRING AND SOEHNE GMBH SUNKIST GROWERS CF BOEHRING AND SOEHNE GMBH LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO PENICK CORP MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC EASTMAN CHEMICAL CO NEW DRUG INSTITUTE CHEM SPECIALTIES CO INC CHEM SPECIALTIES CO INC CF BOEHRING AND SOEHNE GMBH MERCK AND CO INC NEW DRUG INSTITUTE STERO-KEMS CO NOT AN ASSIGNED NUMBER CITRUS & CANNED PRODUCTS ASSOCIATION NATIONAL RESEARCH COUNCIL NEW DRUG INSTITUTE WORTHINGTON BIOCHEM CORP INTERNATIONAL SPECIALTY PRODUCTS COLLETT-WEEK CORP ELI LILLY AND CO CHATTEM CHEMS DIV CHATTANOOGA MEDICINE CO NEW DRUG INSTITUTE HESPERDIN PLASTIC BAG CONTAINERS NDI FORMULA 200 DESOXYRIBONUCLEASE, PANCREAIC POLYVINYL PYRROLIDONE-IODINE 10 CRYSTALLINE RESERPINE FORM R. VOMITORIA TOPICAL ANESTHETIC COMPOUND C-10 TETRAHYDROXY DIALUMINUM MAGNESIUM DIGLUTAMATE NDI. FORMULA 156 SUBJECT COBALT NRC.MEETING $ OTHER MEETINGS CARBOPOL 934, 940NF, 910NF, AND 941NF RAUSERFIA TABLETS RESERPINE P.E. VERARUM, MEER 4-5% MIXED SILICONES RESERPINE CONCENTRATE GLUCURONO-LACTONE $ THE SALTS OF GLUCURONIC ACID DIPHENYL-P-PHENYLENEDIAMINE HYDROCORTISONE,FREE ALCOHOL CRYSTALLINE TRYPSIN WESCODYNE RESERPINE 100% PURE AIKALOID $ RAUWOLFIA SERPENTINA BENTH BIOFLAVONOIDS RESERPINE PURE ALKALOID $ RAUWOLFIA VOMITIORIA SPECIFICATIONS AND METHODS OF ASSAY UTERASE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. D-ALPHA-TOCOPHERYL POLYETHYLENE GLYCOL 1000 SUCCINATE RAUWOLFIA SERPERTINA WHOLE ROOT,MANNITOL HEXANITRATE , RESERPINE PURE CRYSTALLINE COMPOUND PRONAL (BULK) RESERPINE PURE CRYSTALLINE COMPOUND PRONA (BULK) RESERPINE OHIO AGRICULTURE EXPERIMENT STATION MASSIVE VIT D FOR MILK FEVER PREVENTION

4Q2012

PROCESS $ CONTROL DATE CONCERNING MANUFACTURE OF 2-ACETYLAMINA ETC. RESERPINE;PROTOVERARINES A&B;SUCROSE;STARCH;LACTOSE;ACACIA;MAGNESIUM RALUBEN

Page 5

4Q2012EXCEL DMF# 188 189 190 191 C 192 193 194 I 195 196 I 197 198 199 200 I 201 202 A 203 204 205 206 207 I 208 I 209 210 211 212 213 214 215 216 I 217 218 I 219 220 I I 12/8/1958 7/23/1956 I II 7/9/1956 1/1/1940 I I I I I I I II II II 5/23/1956 5/26/1959 1/1/1940 1/1/1940 7/13/1956 1/1/1940 5/21/1965 7/16/1956 I 5/24/1956 I N N I 4/30/1956 5/9/1956 II 1/1/1940 I II IV 1/1/1940 3/4/1964 I I I 5/2/1956 4/9/1956 1/1/1940 3/29/1956 I 3/8/1956 5/1/1956 I I 2/2/1956 2/17/1956 2/16/1956 STATUS Type SUBMIT DATE I I I II II 1/20/1956 1/1/1940 1/24/1956 1/24/1956 HOLDER WYETH INC SUBJECT MANUFACTURING: METHODS AND CONTROLS

4Q2012

COLORADO AGRICULTURAL & MECHANICAL DIETHYLSTILBESTROL IN CATTLE FEEDS --SAFETY OF USE OF COLLEGE ABBOTT LABORATORIES PHARMACEUTICAL SYSTEMS FOR THE CONTROL OF MANUFACTURE PROCESSING $ PACKING OF DRUGS PRODUCTS DIV MALLINCKRODT INC PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) (ESUB) AS MANUFACTURED IN ST. LOUIS, MISSOURI MALLINCKRODT INC RESERPINE FINE CHEMICALS OF CANADA LTD PENNWALT CORPORATION PHARMACEUTICAL DIV CF BOEHRING AND SOEHNE GMBH INSTITUTE FOR THE STUDY OF ANALGESIC & SEDATIVE DRUGS UPJOHN CO CHEM SPECIALTIES CO INC NEW DRUG INSTITUTE LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO PENICK CORP INTERNATIONAL FLAVORS AND FRAGRANCES INC ER SQUIBB & CO/NJ NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER TREEMOND CO NEW YORK QUININE & CHEMICAL WORKS INC BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO UPJOHN CO SB PENICK & CO MALLINCKRODT INC PHARMACRAFT INC SOCIETE DES LABORATOIRES LABAZ SOCIETE DES LABORATOIRES LABAZ ARCHIMICA LTD PHARMACEUTICAL PRODUCTS COMPANY INC SUMNER CHEMICAL COMPANY INC LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO ANHEUSER BUSCH INC FRANK SAMUEL & COMPANY INC RESERPINE (BULK) DIHYDROCODEINE BITARTRATE ANHYDROUS TESTING FACILITIES FOR RAW MATERIALS & FINISHED GOODS COMBINED ADRENAL HORMONE ANTIBIOTIC THERAPY RAUNORMINE FERROUS FUMARATETOLERON ZIRCONIUM SULFANILAMIDE -2,4-DIMETHOXY-5-TRIAZINE (HB-182) CARNITINE CARNITINATE DICHLORIDE TCCTRICLOCARBAN (3,4,4'-TRICHLORO CARBANILIDE) A DESCRIPTION OF THE FACILITIES & OPERATING PROCEDURES POTASSIUM PARA AMINOSALICYLATE STYLOMYCIN (PUROMYCIN) VITA-BUSCH-12 CONCENTRATE POWDERED WHOLE RAUWOLFIA SERPENTINA ROOT RESERPINE CONTROL PROCEDURES MANUFACTURING ANTIDIABETIC COMPOUND BZ 55 REPORT OF MEETING ORINASE HORMONE AQUEOUS SUSPENSION HYDROCORTISONE ESKASUL MANUFACTURING DETAILS GRAMICIDIN ALVA FLAVORS, SEALVA FLAVORS STILBETIN SUPPLEMENT 50 (DIETHYLSTILBESTROL IN POLYETHYLENE GLYCOL)

Page 6

4Q2012EXCEL DMF# 221 222 223 224 225 I 226 I 227 228 229 230 231 232 233 234 235 I 236 237 238 I 239 240 241 I 242 243 I 244 I 245 246 I 247 248 249 250 I 251 252 I 253 I 4/27/1957 I II 4/12/1957 1/1/1940 I I I II 3/14/1957 10/5/1953 3/14/1957 1/1/1940 I 2/25/1957 4/5/1957 II 1/1/1940 I II II 1/1/1940 2/7/1957 I A II 2/8/1957 1/11/1957 1/29/1957 N I 11/13/1956 11/2/1956 I I I I I I I I II II II 4/8/1957 10/12/1956 1/1/1940 1/1/1940 1/1/1940 11/1/1956 1/1/1940 12/11/1956 1/1/1940 II 5/24/1956 STATUS Type SUBMIT DATE I I I I II 7/18/1956 8/7/1956 8/6/1956 8/1/1956 1/1/1940 HOLDER GALAT ALEXANDER SB PENICK AND CO ORIG SOCIETE DES LABORATOIRES LABAZ REHEIS CHEMICAL CO SUBJECT N-(3'DIMETHYLAMINO)PROPYL PHENOTHIAZING HCL (PROMAZINE HCL) AMMOIDIN (8-METHOXYPSORALEN, XANTHATOXIN) SODIUM DI-TERTIARY BUTYL-NAPHTHALENE SULFONATE SODIUM ALUMINUM CHLORHYDROXY LACTATE COMPLEX(CHLORACEL)

4Q2012

ABBOTT LABORATORIES PHARMACEUTICAL DIETHYLSTILBESTROL PWD & DIETHYLSTILBESTROL 50% SUSPEN. IN SOYBEAN OIL PRODUCTS DIV BRISTOL LABORATORIES INC DIV BRISTOL CALCIUM AMPHOMYCIN OINTMENT MYERS CO ELI LILLY AND CO CHLORDIETHYLNOL (DIETHYL CHLORO ETHYNYL CARBINOL) AMERICAN CYANAMID CO NEW YORK ACADEMY OF SCIENCES CHEMO PURO MFG CO VA MEDICAL CENTER PENCO OF LYNDHURST INC WALLERSTEIN CARBIDE AND CARBON CHEMS CO DIV UNION CARBIDE AND CARBON COR NOT AN ASSIGNED NUMBER AMERICAN ROLAND CORP ELLAY RUBBER COMPANY DIV WR GRACE AND CO GANE & INGRAM INC PHARMACIA AND UPJOHN SYNTEX LABORATORIES INC SUB SYNTEX CORP APOTHEKERNES LABORATORIUM A/S ARMOUR LABORATORIES DIV ARMOUR PHARMACEUTICAL CO ARMOUR LABORATORIES DIV ARMOUR PHARMACEUTICAL CO CHAS PFIZER AND CO INC STERWIN CHEMS INC SUB STERLING DRUG INC NORDSON PHARMACEUTCAL LABS INC CARLEN CORP ER SQUIBB & SONS AEROSOL OT-B POWDER MIX MEETINGS, MISCELLANEOUS PIPERAZINE PREPARATIONS CHEMOTHERAPY IN PSYCHIARY METHOCARBAMOL TYROTHRICIN & GRAMICIDIN PIPERAZINE, TECHNICAL

SYNTHETIC FERTILIZERS & CHEMICALS INC P HYDROXYPHENYLSALICYLAMIDE

RESERPINE FROM RAUWOLFIA VOMITORIA VINYL SHEETING & GRANULES - 0445X3 BENACTYZINE HCL NORETHINDRONE PREDNISONE, CRUDE AND CRYSTALLINE NEOMYCIN SULFATE 3,3' - ALLYLDIETHYLSTILBESTROL & 3,3' - ALLYL HEXESTROL VITAMIN B12 CONC. (FEED GRADE MILORGANITE)(VET MED) COBALAMIN CONCENTRATE SOLUTION SOLUTION OF COBALAMINE CONCENTRATE LEVONOR (1-AMPHETAMINE ALGINATE) CARLENDACIDE: VAGISEC (NAME UNDER WHICH MK'T BY JULIUS SCHMID, INC.) PACKAGING OF SQUIBB RADIOPHARMACEUTICALS

JENSEN-SALSBERY LABS DIV RICHARDSON- XYLOCAINE MERRILL INC MEER CORP RESERPINE JENSEN-SALSBERY LABS DIV RICHARDSON- SODIUM POLYTHIONATE SOLUTION(VET MED) MERRILL INC MERCK AND CO INC AQUEOUS SOLN RADIO-ACTIVE VITAMIN B12

Page 7

4Q2012EXCEL DMF# 254 I 255 256 257 258 I 259 I 260 261 262 263 264 265 266 I 267 I 268 269 270 271 272 I 273 274 I 275 I 276 277 278 279 280 281 282 283 284 285 286 I I I I I I A I I I I I II II II II 11/1/1957 11/6/1957 10/28/1957 8/8/1960 11/19/1957 11/21/1957 11/14/1957 12/5/1957 12/18/1957 1/16/1965 2/5/1958 1/1/1940 I II II 9/3/1957 1/1/1940 I I I I II II II II 1/1/1940 9/25/1957 1/1/1940 1/1/1940 1/1/1940 I 8/21/1951 I I I I I I II II II II 7/9/1957 5/15/1957 1/1/1940 6/18/1957 7/26/1957 1/1/1940 1/1/1940 6/13/1957 SYNTEX LABORATORIES INC SUB SYNTEX CORP ROUSSEL CORPORATION ROBECO CHEMICALS INC UPJOHN CO ROHM AND HAAS CO SB PENICK AND CO ORIG RHODIA INC I I I I II 5/1/1957 1/1/1940 4/2/1957 5/23/1967 STATUS Type SUBMIT DATE IV 4/4/1957 HOLDER SYBRON CORPORATION CHEMICAL DIVISION SOCIETE DES LABORATOIRES LABAZ FERRING AB RK LAROS CO GENERAL PACKAGING SERVICE SUBJECT IONAC C-269 AS MFG. IN NEW JERSEY (FORMERLY PERMUTIT COMPANY) ADRENOCHROME MONO SEMI CARBAZONE TRICORTAN(VET MED) FERLARON MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. HORMONE COCKTAIL PREDNISONE ROBANE NEOMYCIN SULFATE 0.5GM, COMMERICIAL GRADE, NOT USP POLYMER MC 2242 NEOMYCIN PALMITATE HYDROCHLORIDE6484 R.P. (VET MED)

4Q2012

JENSEN-SALSBERY LABS DIV RICHARDSON- STEROSAN (VET MED) MERRILL INC IVERS-LEE DIV BECTON-DICKINSON AND CO MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. RHODIA INC PIPERAZINE DIHYDROCHLORIDE AMMONIUM)RHODEX(VET MED) NORDA ESSENTIAL OIL AND CHEM CO INC CHAS PFIZER AND CO INC MERCK AND CO INC NEW YORK QUININE & CHEMICAL WORKS INC DOW CHEMICAL CO MICHIGAN DIV BIS (2-HYDROXY-5-CHLORO PHENYL) SULFIDE NEOMYCIN SULFATE(VET MED) NEOMYCIN SULFATE HYDROCORTISONE, HYDROCORTISONE ACETATE & CORTISONE ACETATE DISIDIUM DIHYDROGEN VERSENATE, A.R.

F.X. GASSNER, COLORADO STATE TESTOSTERONE & DIETHYLSTILBESTROL-CATTLE FEED MIXED W/INGREDS--SAFETY? UNIVERSITY ABBOTT LABORATORIES PHARMACEUTICAL DEXOXYEPHEDRINE HCL PRODUCTS DIV SYNTEX SA PREDNISOLONE NYSCO LABS INC ORTHANA KEMISK FABRIK A/S GENERAL MILLS INC SYNTEX SA MEDA PHARMACEUTICALS INC PETER HAND FOUNDATION NEW DRUG INSTITUTE SB PENICK AND CO ORIG SPARKS CORP EMERY PERSONAL CARE PRODUCTS GROUP PENTA - ERYTHRITOL TETRANITRATE TIMED DISINTEGRATION CAPSULES CORTICOTROPIN - GEL L-ARGININE MONHYDROCHLORIDE AND L-ARGININE AND L-GLUTAMATE 17A - ACETOXY PROGESTERONE 2 HYDROXY-METHYLENE-17 ALPHA METHYL-DIHYDRO-TESTOTERONE VITAMIN A-DESOXYCHOLIC ACID COMPLEX SYNTHESIS OF RESPERINE RESCINNAMINE PROCEDURE FOR HANDLING MEDICAL TABLETS ETHOXYLAN

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4Q2012EXCEL DMF# 287 I 288 289 I 290 291 I 292 I 293 294 I 295 296 I 297 I 298 299 I 300 I 301 302 I 303 304 I 305 306 307 308 309 I 310 311 312 313 314 315 I 316 317 I I 12/19/1958 12/22/1958 I I I I I II II I 1/1/1940 10/27/1958 11/4/1958 11/6/1958 10/24/1958 11/21/1958 I I I I IV I 8/5/1958 9/29/1958 9/29/1958 10/1/1958 10/22/1958 RALSTON PURINA CO GIVAUDAN CORPORATION AMERCHOL CORP CHEMO PURO MFG CO CHATTEM CHEMS DIV CHATTANOOGA MEDICINE CO CHEMICALS INC SE MASSENGILL CO-ORIG ICN PHARMACEUTICALS INC RHODIA INC PFIZER AND CO SYNTEX LABORATORIES INC SUB SYNTEX CORP RHODIA INC MF'G PROCEDURES FOR PURINA CHOWS GIV - TAN F OIL & LOTION - PHARMACOLOGY, SPECS. CHOLESTEROL & LANOLIN PRODUCTS OXELADIN CITRATE PHARAMCOLOGY, CLIN REPT., MF'G PROCESS ZIRCONIUM ALUMINUM CHLORHYDRATE ANTIPERSPIRANT & TOXCITY TESTS DRXTRAN POWDER-SPEC & MFG PROCESSES CONTROL PROCEDURES STANDARD OPERATION PROCEDURES PACKAGING OPERATIONS A MURRAY HILL PLANT 4632 R.P. MALEATE TERRAMYCIN-HYGROMYCIN PREMIX 19-NOR-17A-ETHINYL-TESTOSTERONE-17 B ACETATE 3828 R.P. FUMARATE - MF'G PROCEDURE I II 8/29/1958 9/18/1958 I I V 6/23/1958 7/16/1958 II 1/1/1940 I II 5/22/1958 1/1/1940 II 5/19/1958 I 4/29/1958 1/16/1958 I II 4/14/1958 4/9/1958 II 1/1/1940 I I 3/19/1958 3/19/1958 I 3/4/1958 3/10/1958 STATUS Type SUBMIT DATE 12/24/1957 HOLDER DISTILLATION PROD INDS DIV EASTMAN KODAK CO GENERAL ANILINE AND FILM CORP LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO UPJOHN CO SUBJECT MYVARET VITAMIN A FEED SUPPLEMENT RETINENE QUINOLATE(VET MED) DITHIAZANINE IODIDE (3,3'-DIETHYLTHIODICARBOCYANINE IODIDE) AEROSOL OT-N COMPRESSED TABLETS UPRIN, 5GR(ASPIRIN ANHYDRIDE)

4Q2012

SMITH KLINE & FRENCH LABS DIV GENERAL CONTROL PROCEDURES SMITHKLINE BECKMAN CORP JENSEN-SALSBERY LABS DIV RICHARDSON- FRAMYCETIN (SOFROMYCIN ROUSSEL) MERRILL INC MERCK AND CO INC HYDROCORT. 21-PHOSPHATE & NEOMYCIN SO4--OPTHAL. SOL. 0.5% & INJECT DISTILLATION PROD INDS DIV EASTMAN KODAK CO SCHUYLKILL CHEM CO SYNTEX LABORATORIES INC SUB SYNTEX CORP LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO SOCIETE DES LABORATOIRES LABAZ INDOCYANINE GREEN ALUMINUM ALLANTOINATES - SPECS, TOXICITY & CLINICAL TESTS 19 NOR - 17 ALPHA - METHYL - TESTOSTERONE SULFACHLOROPYRAZINEM - MFR & SPECS PROPYNYL CYCLOHEXANOL CARBAMATE

JENSEN-SALSBERY LABS DIV RICHARDSON- DEQUADIN(COMMON NAME DEQUALINIUM CHL) MERRILL INC JENSEN-SALSBERY LABS DIV RICHARDSON- TEOQUIL MERRILL INC HOFFMANN LA ROCHE INC FACILITIES AND CONTROLS --TRETINOIN JENSEN-SALSBERY LABS DIV RICHARDSON- SOMATOTROPIC HORMONE - JOURNAL REFERENCES MERRILL INC ELI LILLY AND CO 1 - CYCLOPPENTYL - 2 - AMINO PROPANE UPJOHN CO CHLORPROPAMIDE TABLETS-PHARMACOLOGY, CLIN RPTS,MFG'S PROCEEDS. & CNTRL

SYNTHETIC FERTILIZERS & CHEMICALS INC N-DIETHYLVANILLAMIDE (MFR. & SPECS)

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4Q2012EXCEL DMF# 318 319 320 I 321 322 I 323 I 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 I 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 A I I I I I I I I I I I I I I I I II II I II II 7/8/1959 7/13/1959 8/6/1959 8/16/1959 8/18/1959 8/24/1959 9/10/1959 9/4/1959 10/14/1959 10/19/1959 10/16/1959 11/2/1959 11/2/1959 11/16/1959 11/16/1959 12/2/1959 12/11/1959 I I I I I I I I I I I I I I II II II IV II I 1/21/1959 1/29/1959 2/9/1959 2/18/1959 3/2/1959 3/19/1959 3/4/1959 3/31/1959 4/14/1959 4/13/1959 4/20/1959 1/1/1940 5/18/1959 1/1/1940 6/23/1959 1/19/1959 I IV 1/7/1959 1/15/1959 ICI AMERICAS INC SPAN 85 - SPECS & ASSAY METHODS STATUS Type SUBMIT DATE I I III 12/31/1958 12/22/1958 1/6/1959 HOLDER ICI AMERICAS INC JORDAN KENNETH L MD WALLERSTEIN CO DIV TRAVENOL LABS INC SUBJECT ARLACEL; 165 ARLACEL; 161 MYRJ 59 - SPECIFICATION MEPHENESIN & PROCAINE HCL MYLASE, PHARMACEUTICAL

4Q2012

AYERST LABORATORIES INC DIV AMERICAN MF'G CONTROL PROCEDURES - SPECS FOR COMMONLY USED IN RAW MATERIALS HOME PRODUCTS CORP VICTOR M HERMELIN CO DIV K-V RAUVERTIN (IMPROVED) TABLETS (SPACE RELEASE) PHARMACAL CO SB PENICK AND CO ORIG CANDICIDIN SEARLE CHEM INC PARKE DAVIS DIV WARNER LAMBERT CO GEIGY CHEM CORP RUSPACK CORP DOW CHEMICAL CO MICHIGAN DIV MONSANTO COMPANY PABST LABS DIV PABST BREWING CO UPJOHN CO SOLVAY PHARMACEUTICALS ELI LILLY AND CO NOVO NORDISK AS CHEMICALS INC RHODIA INC KNOLL PHARMACEUTICAL CO UNIT BASF K&F CORP RHODIA INC UPJOHN CO STECKER CHEMICALS INC KV PHARMACEUTICAL CO SB PENICK AND CO ORIG GEIGY CHEM CORP AVECIA INC MINERALS & CHEMICALS PHILIPP CORP MONSANTO COMPANY WARNER LAMBERT CO ARMOUR PHARMACEUTICAL CO SB PENICK AND CO ORIG PRINCETON LAB PRODS CO ELI LILLY AND CO PHARMACIA LABS INC WALLERSTEIN GEIGY CHEM CORP MANUFACTURING PROCESSES 6A-METHYL-17-A-ACETOXYPROGESTERONE 1-DESOXYEPHEDRINE 3,5,3,4,-TETRACHLOROSALICYLANILIDE PROCEDURES FOR PRODUCING PHYSICIANS SAMPLES DOW 132 (4-TERT-BUTYL-2-CHLOROPHENYLMETHYL METHY PHOSPHORAMIDATE) HEMA (HYDROLYZED ETHYLENE MALEIC ANHYDRIDE) RESIN ZYMO-PABST SOLKETAL (GLYCEROL 1,2 - ISOPROPYLIDENE ETHER) DUVADILAN (ISOXSUPRINE HCL) MYRISTYL - 3 - HYDROXYBUTYLAMINE HCL - COMPOUND 06537 AMYLASE CONCENTRATE, CRUDE BACTERIAL IRON - HYDRODEXTRAN SPIRAMYCIN--MFG PROCEDURES DONDREN (MINERAL OIL) IGEPAL CO-630 SPECIAL STYRENE - MALEIC ACID COPOLYMER-TOXIC. DAA, CLIN REPTS & PHYSI CHARAC ASC-4, BRAND OF DIAPHENE NOLAMINE REPEA ACTION TABLETS PHOLCODINE - MFR' & SPECS MFG PROCEDS, ANALYTICAL METHODS & SPECS (SEQUESTRENE NA2CO) SDM-40 (25% ISOSORBIDE DINITRATE IN LACTOSE) MANUFACTURED IN TAMAQUA, PA PHARMASORB - REGULAR & COLLOIDAL SANTOPHEN1, O-BENZYL-P-CHLOROPHENOL PARENTERAL MANUFACTURE MANUFACTURING CONTROL PROCEDURES INOSITOL HEXANICOTINATE TRYPSIN, CHYMOTRYPSIN & RIBONUCLEASE - MF'G PROCEDURES & ASSAYS VORTEL TABLETS LOW MOLECULAR DEXTRAN ENZYMES SEQUESTREN NA FE, MF'G PROCEDURES & SPECS

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4Q2012EXCEL DMF# 356 357 358 I 359 360 361 362 I 363 I 364 365 I 366 367 I 368 369 370 371 372 I 373 374 375 376 377 I 378 379 I 380 I 381 382 383 384 385 386 I 387 388 I I II 7/11/1960 7/13/1960 I I I I I II II II II 5/12/1960 6/16/1960 6/27/1960 7/5/1960 7/7/1960 6/27/1960 6/6/1960 I II V 5/16/1960 5/25/1960 I I I I II II II 3/23/1960 3/31/1960 4/5/1960 4/28/1960 4/29/1960 A I I I III IV 2/24/1960 2/25/1960 2/29/1960 3/14/1960 3/21/1960 I II II 2/16/1960 2/17/1960 I IV 2/8/1960 3/3/1960 I 2/5/1960 KNOLL PHARMACEUTICAL CO UNIT BASF K&F CORP WALLERSTEIN RHONE POULENC PHARMACEUTICALS DIV RHONE POULENC INC KV PHARMACEUTICAL CO MF'G PROCEDURES, & CONTROLS AMYLOLYTIC AND PROTEOLYTIC ENZYMES EMULPHOR EL - 620 & EL - 719 PYRILAMINE - PHENYLEPHRINE SUSTAINED ACTION CAPSULES I I I II II 1/21/1960 1/21/1960 2/1/1960 1/27/1960 STATUS Type SUBMIT DATE I I II II 12/17/1959 1/6/1960 1/13/1960 HOLDER AMERICAN CYANAMID CO HELENA RUBINSTEIN INC SYNTEX LABORATORIES INC SUB SYNTEX CORP EASTMAN CHEMICAL CO ROBAPHARM LTD LABAZ LABORATORIES SUBJECT NEOMYCIN BASE - MF'G PROCEDURES & SPECS WHITE MAGNOLIA PERFUME OIL, FORMULATION 6A - CHLORO - PREDNISONE ACETATE (MFG PROCEDURE & SPECS) MYVACET MANUFACTURED IN KINGSPORT, TENNESSEE. ROBUDEN - MF'G PROCEDURES & SPECS

4Q2012

ETHYL (DIIODO-HYDROXY-BENZOYL) COUMARONE - MF'G PROCEDURES & SPECS

EATON LABS DIV NORWICH PHARMACAL CO NIDRAFUR MIX

WAITAKI INTERNATIONAL BIOSCIENCES SUB TRYPSIN & A - CHYMOTRYPSIN - PREPARTION & ASSAY METHODS WAITAKI CANADA LTD GIVAUDAN FLAVORS CORP FLAVOR FORMULATIONS BENZOL PROD CO HAYNIE PRODS REED-LANE INC VICTOR M HERMELIN CO DIV K-V PHARMACAL CO WORTHINGTON BIOCHEM CORP SB PENICK AND CO ORIG JOHN MANVILLE PRODUCTS CORP ROUSSEL CORPORATION ROYAL NETHERLANDS FERMENTATIONS LTD ELI LILLY AND CO HESS AND CLARK CO DIV RICHARDSONMERRELL INC LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO GB FERMENTATIONS ELI LILLY AND CO REYNAUD LTD SANOFI AVENTIS CHIMIE WYETH AYERST LABORATORIES INC TRANS 2 - PHENYLCYCLOPROPYL AMINE SULFATE - MANUF PROCEDURES ADMIRAL 123 - MF'G PROCEDURES CONTRACT PACKAGING FACILITIES LOCATED IN WAYNE, NJ DELFETA-SED PLUS T STEDYTABS DESOXYRIBONUCLEASE, PANCREAIC PHENAZOCINE HYDROBROMIDE - MF'G PROCED., SPECS, CLIN. & TOXICITY DATA MICRO-CEL & CELKATE DESERPIDINE SYNTHETIC PIMARICIN IMIDAZOLIUM BROMIDE DERIVAIVE NIHYDRAZONE - FIELD RESEARCH DATA FORMULATE FOR VARIOUS STANDARD COATING SOLUTIONS ,LAKEDYE PROLASE 300 TYLOSIN PERBRO CLOUD 1-(A-HYDROXYETHYL)-2-METHYL-5-NITRO-IMIDAZOLE,A NEW TRICHOMONOCIDE DIETHYLSTILBESTROL IMPLANTATION PELLETS

ABBOTT LABORATORIES PHARMACEUTICAL GALLIMYCIN -10+ ZOALENE PRODUCTS DIV NORWICH PHARMACAL CO FURALTADONE MASTITIS PREPARATION - SQUEEJET DISPENSER GEIGY CHEM CORP TINOPAL GS

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4Q2012EXCEL DMF# 389 390 391 392 I 393 394 395 396 397 I 398 399 I 400 I 401 402 403 I 404 I 405 I 406 407 408 409 410 411 412 413 I 414 415 416 417 418 A 419 I 420 421 A N IV 12/7/1960 1/3/1961 LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO CREMER OLEO GMBH AND CO KG NOT AN ASSIGNED NUMBER I I I A II II II 12/5/1960 12/21/1960 12/15/1960 12/28/1960 1/3/1961 I I I I I I I II II II II II 11/7/1960 11/7/1960 11/4/1960 11/10/1960 11/14/1960 11/25/1960 11/28/1960 11/28/1960 II 10/27/1960 II 10/27/1960 I I II II 10/10/1960 1/1/1940 10/20/1960 10/6/1960 I I IV 9/19/1960 10/3/1960 UPJOHN CO I I A I I I II II I 8/1/1960 8/2/1960 8/10/1960 1/1/1940 9/6/1960 STATUS Type SUBMIT DATE I I I II 7/15/1960 1/17/1960 7/18/1960 7/25/1960 HOLDER RP SCHERER CORP DRAGOCO INC DOLE CO SYNTEX LABORATORIES INC SUB SYNTEX CORP MCMILLEN FEED MILLS GENERAL MILLS INC DSM NUTRITIONAL PRODUCTS INC BIO-RAMO DRUG CO INC SHARP CORP SUBJECT FERROUS CITRATE AZULENE BROMELAIN - COMMERICAL GRADE MF'G PROCEDURES MFG OF BULK--19-NOR-17A-ETHINYL-TESTOSTERONE-17B-MONOENANTHATE

4Q2012

METHODS IN FACILS & CONTROLS FOR THE MFG, PROCESSING, PACK. OF DRUGS METHODS FACILS & CONTROLS - FOR MFG PROCESSING & PACK. OF DRUGS. 5% D-METHORPHAN HYDROBROMIDE ADSORBATE POWDER IRON POLYSACCHARIDE RAW MATERIAL USED IN MFG OF DI-FERRON INJECTION MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CONSHOHOCKEN, PENNSYLVANIA. MANUFACTURING ,PACKAGING AND CONTROLS PROCEDURES-THIS IS A VET MED DMF

EMERY PERSONAL CARE PRODUCTS NIMLESTROL; LANFRAX; LANTROL; LANFRAX WS55 (LANOLIN PRODUCTS) GROUP CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CONTROLS, RAW MATERIAL SPECIFICATIONS CORP CHAS PFIZER AND CO INC OLEANSOMYCIN AND COCCIDIOSTAS IN POULTRY FEED ICI AMERICAS INC LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO RHONE POULENC PHARMACEUTICALS DIV RHONE POULENC INC RHONE POULENC PHARMACEUTICALS DIV RHONE POULENC INC SB PENICK AND CO ORIG WORTHINGTON BIOCHEM CORP WALLERSTEIN SYNTEX SA ER SQUIBB & SONS SYNTEX SA WITHMORE FEEDS INC SORBITAN MONOOLEATE (SPAN 80)(VET MED) REFERRED TO PESTICIDE BRANCH BIPHENAMINE HYDROCHLORIDE IGEPAL CO 887 (SAME AS IGEPAL 880) CONTRLS & TOXICITY BIOPAL VRO-20 NEODECYLLIN (NEOMYCIN UNDECYLENATE) CHYMOTRYPSIN (MANUF PROCEDURE) CELLASE 1000 PARAMETHASONE ACETATE--MANUF PROCEDS, PICCOLITE RESIN S 115 L DROMOSTANOLONE PROPIONATE ZOALENE (IMPROVED HIGH ENER-G-BROILER RATION Z MEDICATED W/ ZOALENE)

ABBOTT LABORATORIES PHARMACEUTICAL DIMETHADIONE PRODUCTS DIV SYNTEX SA FLURANDRENOLIDE SYNTEX SA SYNTEX SA WATSON LABORATORIES INC DR REDDYS LABORATORIES LTD 62 FLUORO-16 2 METHYL HCL 62 FLUORO - 16 2 METHYL PREDNISOLONE ACETATE 6- CHLORO - 6 - DEHYDRO- 17A - ACETOXY PROGESTERONE MESTRANOL3-METHOXY-17-ETHINYL-ESTRADIOL- MANUF PROCEDURES FLUOCINOLONE ACETONIDE MANUFACTURED IN FREEPORT, BAHAMAS AND CUERNAVACA, MEXICO. BUTYLPHENAMIDE WITEPSOL, HARD FAT SUPPOSITORY BASE

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4Q2012EXCEL DMF# 422 423 424 425 I 426 427 428 429 430 431 432 433 434 I 435 436 437 I 438 439 440 441 442 443 444 I 445 446 447 448 449 450 451 452 453 454 455 456 I 457 458 I I I 12/12/1961 12/28/1961 I I N I A I I I A I I II II IV 7/6/1961 9/18/1961 9/22/1961 9/29/1961 10/21/1961 7/13/1965 12/7/1961 12/12/1961 12/11/1961 II 8/21/1961 8/28/1961 I I I I I N 8/9/1961 II IV 6/30/1961 6/6/1961 7/12/1961 7/21/1961 2/10/1961 I N 6/30/1961 6/22/1961 I I I I I I I I II II II 2/6/1961 4/4/1961 4/11/1961 11/21/1960 4/18/1961 4/27/1961 4/28/1961 5/12/1961 6/22/1961 STATUS Type SUBMIT DATE I I I I 1/19/1961 2/24/1961 3/1/1961 3/16/1961 HOLDER GEIGY CHEM CORP HALES & HUNTER SB PENICK AND CO ORIG VICTOR M HERMELIN CO DIV K-V PHARMACAL CO UNION CARBIDE CORPORATION DUPHAR BV RP SCHERER CORP KAY-FRIES CHEMS SB PENICK AND CO ORIG STRONG COBB ARNER INC HOFFMANN LA ROCHE INC H LUNDBECK AND CO AS IMC CHEMICAL GROUP INC SUB INTL MINERALS & CHEM CORP RHODIA INC NOT AN ASSIGNED NUMBER VICTOR M HERMELIN CO DIV K-V PHARMACAL CO DOW CHEMICAL CO MICHIGAN DIV UNION CARBIDE AND CARBON CORP NATIONAL STARCH & CHEMICAL CORP PRODOTTI CHIMICI DOTTORI RE CHEMAGRO CORP NOT AN ASSIGNED NUMBER LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO GEIGY CHEM CORP CHAS PFIZER AND CO INC NOT AN ASSIGNED NUMBER ORTHO PHARMACEUTICAL CORP FMC CORP FMC BIOPOLYMER DIV SCHWARTZ BIORES INC NYSCO LABS INC NYSCO LABS INC FABBRICA ITALIANA SINTETICI SPA PRODOTTI CHIMICI DOTTORI RE FINE ORGANICS INC INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA ALLIED MILLS, INC. RT VANDERBILT CO QUALITY CONTROL PROCEDURE AVICEL MICROCRYSTALLINE CELLULOSE THIOGEL CHLORPHENIRAMINE MALEATE 4MGS TIMED RELEASED PELLETS PHENYLPRIPANOLAMINE HCL 50MG TIMED RELEASE PELLETS NITROFURANTION NITROFURANTOIN TEMASEPT CHLOROTHIAZIDE (BULK) - HYDROCHLOROTHIAZIDE FEED MANUF PLANTS AND CONTROL LABORATORIES WAYNE FEEDS VANCIDE ZP AND VANCIDE ZP DISPERSION SULFACHLOROPYRIDAZINE IRGASAN CF3 L'-LYSINE MONOHYDROCHLORIDE FACILITIES & CONTROL (SPOT WELDING) FACILITIES & CONTROLS (METHOXY FLURANE) UCON FLUID 50-HB-660 INSTANT CLEARJEL MEPROBAMATE NEGUVON SUBJECT CHEL 330 ACID (DIETHYLENETRIAMINE PENTACETIC ACID) STANDARD OPERATING PROCEDS FOR MANUF MEDICATED FEEDS MEPHENOXALONE- METHODS OF MANUF.

4Q2012

FACILS & CONTROLS USED FOR MANUF PROCESSING & PACKAGING OF NEW DRUGS SILICONE X-251 DYDROGESTERONE(FORMERLY ISOPREGNENONE) FERROUS CITRATE, MANUF SPECS & CLINICAL DATA BUTYLPHENAMIDE GLYCOPYRROLATE VICKS SINUS ANTICONGESTION TIME COVE TABLETS TRI-SPAN AMPROTROPINE RESINATE POWDER CALCIUM - AMPHOMYCIN TROMETHAMINE ETHIONAMIDE

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4Q2012EXCEL DMF# 459 460 461 462 463 464 465 466 467 468 469 470 471 472 473 474 475 476 477 478 I 479 480 I 481 482 483 484 485 486 487 488 I 489 I 490 491 492 493 494 495 496 I I N I I A I II IV II 7/6/1962 7/20/1962 7/25/1962 8/15/1962 II II 6/22/1962 6/27/1962 6/8/1962 I I I I I I I II 4/30/1962 4/26/1962 5/14/1962 5/18/1962 5/29/1962 6/12/1962 6/11/1962 6/12/1962 WORTHINGTON BIOCHEM CORP A WASSERMANN SPA SPENCER LABS DIV UNIMED INC PACO PACKAGING INC CHAS PFIZER AND CO INC CONTINENTAL CAN COMPANY CONTINENTAL CAN COMPANY ARGINASE PRODUCTION MEPROBAMATE SERC PHARMACEUTICAL PACKAGING OPERATION EPITHIAZIDE (P=2105) CONALOY (INTERNAL) CONALOY (EXTERNAL) I II 4/12/1962 4/18/1962 STATUS Type SUBMIT DATE I I I I I I I I A I I I I I I I I I I II II II II II II IV 1/4/1962 1/4/1962 1/8/1962 1/8/1962 2/6/1962 2/7/1962 2/6/1962 2/15/1962 2/15/1962 2/13/1962 2/26/1962 2/26/1962 2/26/1962 3/12/1962 3/21/1962 3/21/1962 3/23/1962 3/28/1962 3/27/1962 2/13/1962 HOLDER RT VANDERBILT CO RT VANDERBILT CO RT VANDERBILT CO PHARMACIA LABS INC SB PENICK AND CO ORIG ELANCO PRODS DIV ELI LILLY AND CO RHODIA INC A WASSERMANN SPA FIS FABBRICA ITALIANA SINTETICI SPA INDUSTRIA CHIMICA MILANESE SPA INDUSTRIA CHIMICA MILANESE SPA SYNTEX SA EI DUPONT DE NEMOURS AND CO DOW CHEMICAL CO MICHIGAN DIV STRONG COBB ARNER INC EI DUPONT DE NEMOURS AND CO METAL & THERMIT CORP NEISLER LABS INC DIV MALLINCKRODT INC CHAS PFIZER AND CO INC ARAPAHOE CHEMS INC DIV SYNTEX LABS INC RT VANDERBILT CO BAXTER LABS INC DIV TRAVENOL LABS INC SUBJECT VANCIDE BL VANCIDE BN METHYL TUADS RHEOMACRODEX BENZOMETHAMINE CHLORIDE HYGROMIX - CHICKENS PIPERACETAZINE TOLBUTAMIDE BULK CHLORDIAZEPOXIDE HCL PROCHLORPERAZINE MALEATE CHLORPROMAZINE HYDROCHLORIDE 2A-METHYL-DIHYDROTESTOSTERONE (CRYSTALLINE) BAYMAL COLLOIDAL ALUMINA BROMINATED SALICYLANILIDE MATRIX GEL SUSTAINED RELEASE SYSTEM

4Q2012

TEREPHTHALIC ACID IN COMBINATION W/ TETRACYCLINES MED. TURKEY FEEDS STANNOUS FLUORIDE DURABOND PRINCIPLE TEREPHTHALIC ACID IN POULTRY FEEDS CONTAINING OXYTETRACYCLINE HYDROXYPHENAMATE VANCIDE 2B TYROTHRICIN CHEMPLEXES

ABBOTT LABORATORIES PHARMACEUTICAL ARSANILIC ACID (SODIUM ARSANILATE) PRODUCTS DIV SEARLE CHEMS INC SUB GD SEARLE AND ANAVAR, PESA CO ELANC0 DIV ELI LILLY & CO CHYMOTRYPSIN TRYPSIN CRYSTALLIZED SALSBURY LABS NOT AN ASSIGNED NUMBER ROHM AND HAAS CO METAL & THERMIT CORP MARKEM IMAJE CORP ICI AMERICAS INC ASPERKINASE PRODUCTION STANNOUS OCTOATE INKS USED ON CAPSULES & TABLETS STANDARD DRUG MIXTURE #35--SDM#35 3-NITRO-4-HYDROXYPHENYLARSONIC ACID

Page 14

4Q2012EXCEL DMF# 497 498 499 500 501 502 503 I 504 505 506 507 508 509 510 511 512 513 514 I 515 516 517 518 519 520 521 522 523 524 525 526 527 I 528 529 530 531 I 532 I 533 I I 3/27/1963 II 4/5/1963 I I N 4/1/1963 IV II 3/25/1963 3/27/1963 I I I I I I N I I I I I I II 3/29/1963 3/19/1963 8/19/1970 3/11/1963 3/14/1963 3/20/1963 II I I 12/19/1962 2/6/1963 2/8/1963 2/15/1963 2/18/1963 2/28/1963 I I I I I I A I N I 1/17/1963 1/22/1963 IV III 10/17/1962 11/14/1962 11/28/1962 12/3/1962 11/30/1962 12/13/1962 1/3/1963 12/28/1962 STATUS Type SUBMIT DATE N I I I A I III 8/24/1962 8/27/1962 8/1/1962 10/8/1962 10/10/1962 10/12/1962 HOLDER NOT AN ASSIGNED NUMBER YARDLEY ELECTRIC CORP IRWIN NEISLER AND CO SCHUYLKILL CHEM CO BD MEDICAL PHARMACEUTICAL SYSTEMS PRIVATE BRANDS CO DEPT OF DEFENSE-ARMY DEFENSE MEDICAL MATERIEL BOARD SCHERING AG PENTAPHARM AG RHODIA INC INTERNATL CHEM & NUCLEAR PHARMS INC ALLERGAN SPA DOG LIFE CORP DOW CHEMICAL CO ROHM AND HAAS CO NOT AN ASSIGNED NUMBER GIST BROCADES LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO SCHERING AG SHELL CHEM CO PILLSBURY CO LEEDS DIXON LABORATORIES INC ORGANON INC COOPERATIVE MILLS NOT AN ASSIGNED NUMBER PFIZER AND CO TANABE SEIYAKU CO LTD WEST CO WITCO CHEM CO INC GENERAL ANILINE AND FILM CORP LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO ALABAMA FLOUR MILLS CALBIOCHEM CORP NOT AN ASSIGNED NUMBER SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP ALBERS MILLING CO SK&F LABS PERSONNEL SUMMARY OF TRAINING AND EXPERIENCE 5-IODO-2-DEOXYURIDINE (IUDR) CURRICULA VITAE DL-CARNITINE HYDROCHLORIDE PLEASE REFER TO D1545 AMD/OR D1546 WHICH REPLACE D524 EMCOL E-607 QUATERNARY AMMONIUM COMPOUND UVINUL MS-40 ORGANIC CHEMICAL RSCH SECTION, PERSONNEL QUALIFICATIONS RED HA BROILER CONCENTRATE NON-MEDICATED FEEDS 5-IODO-2-DEOXYURIDINE FLURANDRENOLONE ACETATE AGOSAN IN 836 (FENYRIPOL) ALLANTOIN - METHIONINE COMPLEXES HYPAK (R) SCF (R) (STERILE) AND BULK (NON-STERILE) SYRINGE SYSTEMS PACKAGING AND CONTROL SPECIFICATIONS 2 PAM CHLORIDE 17 ALPHA-ETHINYL-19-NOR-TESTOSTERONE REPTILASE DIMETRIDAZOLE [EMTRYL] 5-IODODEOXYURIDINE 5-IODODEOXYURIDINE (5IUDR) TABLETTING MIXURE AND FLAVORING TECHNIQUES SENTRY POLYOX WATER SOLUBLE RESINS - NF GRADE RHOZYME J-25 CONCENTRATE SUBJECT

4Q2012

ULTRAVIOLET ABSORBERS (U.V.Q, U.V. 24, & U.V.24 PHARMACEUTICAL GRADE) 17A-ETHINYL-19-NOR-TESTOSTERONE ACETATE DDVP-RESIN (2,2-DICHLOROVINYL DIMETHYL PHOSPHATE) PROCESS EQUIPMENT AND PROCEDURES OPERATING PROCEDURES DEXAMETHASONE METHODS USED IN MANUFACTURING, PROCESSING AND PACKING DRUGS

EQUIPMENT & CONTROL PROCDS FOR MANUF MEDICATED FEEDS FOR ALBERS FEED

Page 15

4Q2012EXCEL DMF# 534 I 535 536 537 538 539 540 541 542 543 544 I 545 546 547 548 549 I 550 551 I 552 553 554 I 555 I 556 557 558 559 560 561 I 562 I 563 I 564 565 I 566 N I V 5/16/1963 5/23/1963 UPJOHN CO STERLING-WINTHROP RES INST DIV STERLING DRUG INC NOT AN ASSIGNED NUMBER BULK CHEMICALS , METHOD OF PREPARATION INVESTIGATIONAL EXEMPTION FOR WIN 18,320-3 (VETERINARY USE) I 5/22/1963 5/28/1963 I I I I I II V II II 5/20/1963 5/20/1963 5/20/1963 11/14/1962 5/21/1963 4/24/1963 5/16/1963 N I II IV 5/17/1963 5/20/1963 I II II 5/20/1963 4/19/1963 I I I I I V II 5/6/1963 5/9/1963 5/10/1963 5/14/1963 5/10/1963 OZARK-MAHONING CO RUSON LABS INC ARMOUR PHARMACEUTICAL CO NUTRENA MILS, DIV OF CARGILL, INC. STERLING-WINTHROP RES INST DIV STERLING DRUG INC BURROUGHS WELLCOME CO MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC NOT AN ASSIGNED NUMBER ARMOUR PHARMACEUTICAL CO SODIUM MONOFLUOROPHOSPHATE I I I N I I I I I IV II V II II 4/25/1963 4/25/1963 12/12/1962 5/1/1963 5/1/1963 4/23/1963 I I 4/9/1963 4/12/1963 4/23/1963 PARKE DAVIS & CO RHODIA INC MASON-KELLER CORP NOT AN ASSIGNED NUMBER GANES CHEMICALS INC WYETH INC SALSBURY LABS ORGANON INC MALLINCKRODT INC WITHMORE FEEDS INC 7 BETA-HYDROXYPROPYL THEOPHYLLINE INVESTIGATIONAL NEW DRUG MASTER FILE EMTRYL TABLETS DEXAMETHASONE INVESTIGATIONAL DRUGS STATUS Type SUBMIT DATE V 3/14/1963 HOLDER CHEMAGRO CORP SUBJECT

4Q2012

STUDY RESIDUE PROBLS RELATED TO U/OF EXPERIMENTAL ORGANOPHOSPHORUS COM QUALIFICATIONS OF PARKE, DAVIS & CO. RESEARCH PERSONNEL ETHOPROPAZINE MASON-KELLER CORPORATION

36% POULTRY CONCENTRATE 291A /44% BROILER CONCENTRATE UNMEDICATED 190A

ASSAY INFOR RUSON LABS [PRINCIPAL QUANTITAIVE DETER QUATERNARY VITAE] PANCREAIC ENZYME CONCENTRATE FACILITIES FOR CARGILL, INC (THIS IS A VETDMF) INVESTIGATIONAL EXEMPTION FOR WIN 5063 (VETERINARY USE) DARVISIL THIABENDAZOLE

CHYMOTRYPSIN CRYSTALLIZED

ONYX CHEM CO DIV MILLMASTER ONYX ISOTHAN Q-75 CORP ABBOTT LABORATORIES PHARMACEUTICAL M-259 (NSC 51954) PRODUCTS DIV ARMOUR PHARMACEUTICAL CO PURIFIED ENZYME CONCENTRATE CHEMAGRO CORP ICI AMERICAS INC RHODIA INC DOW CHEMICAL CO MICHIGAN DIV BAYER 2353 (YOMESAN) BRIJ 30 POLYOXYETHYLENE (4) LAURYL ETHER FLAVORS: PHARMACEUTICAL FLAVOR RF451, IMITATION FLAVOR 520B TROLENE FM MEDICATED PREMIX

AYERST LABORATORIES INC DIV AMERICAN STUDIES ON ORBENIN, CLOXACILLIN , BRI 1621 , AY 6203 HOME PRODUCTS CORP WARNER LAMBERT CO PHARMACEUTICAL PERSONNEL FACILITIES AND OPERATING PROCEDURE RESEARCH DIVISION BAXTER LABS INC DIV TRAVENOL LABS INC RESEARCH AND DEVELOPMENT GROUP

Page 16

4Q2012EXCEL DMF# 567 I 568 569 570 571 572 573 574 575 576 577 578 579 580 581 582 583 I 584 I 585 I 586 587 588 589 590 591 592 593 594 595 596 597 598 599 600 I 601 I 602 I I 6/24/1963 II 6/27/1963 I I I I I I N I I I I I I I II II II II IV II 6/6/1963 7/5/1963 5/31/1963 5/31/1963 6/13/1963 7/11/1963 6/18/1963 6/18/1963 6/7/1963 6/26/1963 6/10/1963 6/10/1963 6/21/1963 5/24/1963 I 5/28/1963 II 3/5/1963 N I I I I I N I I I I I I I I I II I II 6/5/1963 6/11/1963 6/12/1963 6/12/1963 6/11/1963 6/7/1963 6/5/1963 6/11/1963 6/5/1963 II 5/20/1963 5/28/1963 5/31/1963 5/29/1963 6/3/1963 STATUS Type SUBMIT DATE V 5/23/1963 HOLDER STERLING-WINTHROP RES INST DIV STERLING DRUG INC NOT AN ASSIGNED NUMBER NATL INST HLTH CLINCL CTR PHARMACY 3M PHARMS SYNTEX SA SB PENICK AND CO ORIG SB PENICK AND CO ORIG NOT AN ASSIGNED NUMBER CUTTER BIOL DIV MILES LABS INC RHODIA INC RHODIA INC RHODIA INC RHODIA INC BURROUGHS WELLCOME CO FARM BUREAU SERVICES ORGANON INC CIBA GEIGY CORP PHARMACEUTICAL DIVISION AYERST LABORATORIES INC DIV AMERICAN HOME PRODUCTS CORP SANDOZ CONSUMER PHARMACEUTICALS DIV INOLEX CHEM CO DOW CHEMICAL CO MICHIGAN DIV NATL INST HLTH CLINCL CTR PHARMACY RORER PHARM CORP SUB RORER GROUP PARKE DAVIS & CO ADAMHA NIMH ADDICTION RESCTR NOT AN ASSIGNED NUMBER SANDOZ PHARMS CORP DIV SANDOZ INC ROUSSEL CORPORATION AMERICAN CYANAMID CO AMERICAN CYANAMID CO AMERICAN CYANAMID CO NOVO INDUSTRI AS ALBERS MILLING CO. LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO SYNTEX LABORATORIES INC SUB SYNTEX CORP AH ROBINS CO INVESTIGATIONAL DRUGS INOSITOL HEXANICOTINATE CL 45,167 OR STYRYLPYRIDINIUM (INVESTIGATIONNAL DRUG) STYRYLQUINOLINIUM (CL40,001) INVESTIGATIONAL USE SUBJECT COMBINED W/INVEST. EXEMPTION FOR WIN 18,320-3

4Q2012

STATEMENT OF PERSONNEL FACILS AND CONTROLS FOR PROCESSING A NEW DRUG INVESTIGATIONAL NEW DRUG PROCEDURES INVESTIGATIONAL DRUG, 6APLHS-FLUORO-16-ALPHA-HYDROCORTISOME BISMUTH SUBSALICYLATE PASTE DOXAPRAM HCL; AHR-619 MANUF RESCH AND PERSONNEL FILE RSCH FACILS, EQUIPMENT & CONTROLS 11-16 SPIRAMYCIN METHOTRIMEPRAZINE ISOMETAMIDIAM HEVOPHACETOPERANE (LIDEPRAN)(RP8228) HCL PERTINANT DATA ON THE RESEARCH ACTIVITIES DEALERS USING THIS MASTER FILE AND MILL LOCATION DEXAMETHASONE 21-PHOSPHATE PERSONNEL, FACILITIES & TESTING PROCEDS, AND LABELING INVEST DRUGS METHYRIDINE DORSEY LABORATORIES MANUF PROCEDURE FOR HIGH POTENCY LIPASE INVESTIGATIONAL DRUG MASTER FILE FOR FUTURE REFS NOTICES T/B SUBMITT COOPERATIVE STUDY GROUPS OF CLINICAL STUDIES PANEL RECOSEN, INVESTIGATIONAL DRUG VIRAL AND BACTERIAL VACCINES INVESTIGATIONAL DRUGS SKF-5390,ARC VII-B-4;V-B-1;V-C-5;V-A-29

SULFATETHOXYPYRIDAZINE W/& WITHOUT CHLORTETRACYCTINE IN SWINE FEED EXP CRYSTALLINE TRYPSIN - NOVO DELETED 10 - 11 - 63 ALBERS LAB - MIX POULTRY TRIAMTERENE (VET) 6-ALPHA-9-A-DIFLUORO-16-A-METHYL PREDNISOLONE DESIGNATED RS 2177 FACILITIES, METHODS AND PERSONNEL INVESTIGATIONAL DRUG

Page 17

4Q2012EXCEL DMF# 603 I 604 I 605 I 606 607 608 I 609 I 610 611 I 612 I 613 614 615 616 617 618 I 619 620 621 622 623 624 I 625 I 626 627 628 I 629 630 631 632 I 633 634 I I II 8/5/1963 3/8/1963 I I N 8/9/1963 8/8/1963 8/12/1963 I I II 7/24/1963 7/22/1963 8/8/1963 7/2/1963 I I I I I II IV 8/5/1963 7/30/1963 7/17/1963 6/12/1963 7/26/1963 4/25/1963 I I I I N 6/18/1963 5/10/1963 3/14/1963 3/14/1963 7/29/1963 7/30/1963 I 6/11/1963 6/11/1963 6/3/1963 I I II 2/14/1963 7/30/1963 5/31/1963 6/25/1963 7/5/1963 STATUS Type SUBMIT DATE 6/3/1963 HOLDER MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC MERRELL DOW PHARMS INC SUB MARION MERRELL DOW INC WARNER LAMBERT CO PHARMACEUTICAL RESEARCH DIVISION CORVEL, INC. SCHWARTZ BIORESEARCH INC BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO WYETH INC WARNER LAMBERT CO PHARMACEUTICAL RESEARCH DIVISION BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO VA MEDICAL CENTER PROCTER AND GAMBLE CO MALLINCKRODT CHEMICAL WORKS KIERNAN-HUGHES INC NOT AN ASSIGNED NUMBER CIBA PHARMACEUTICAL CO DIV CIBA GEIGY GENERAL INFO-DISCONTINUED INVESTIGATIONAL DRUGS CORP AMERICAN CYANAMID CO SULFATETHOXYPYRIDAZINE AND CHLORTETRACYCLINE(VET) C ALBERT SAUTER CO WALLERSTEIN CUDAHY LABS DIV CUDAHY PACKING CO WISC ALUMNI RES FDTN SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP IVERS-LEE MIDWEST CO INC DIV BECTONDICKINSON AND CO DOMINION PRODUCTS INC PABST LABS DIV PABST BREWING CO PACKAGING OF MEDICATION (BLISTER PACKAGES) DIHYDROXYACETONE (THIS DSENT TO COLOR ADD. ON 9.6.63) ELASTASE FORMULA 7100 (VET) CYTOMEL IMPLANT PELLETS(VET) PACKAGING FACILITIES AND CONTROLS PHARMACEUTICAL FLAVORS #124-B-12 & 121-B-12 5-IODO-2'-DEOXYURIDINE SUBJECT HADACIDIN SOD. DIHYDRATE (NSC 521778) & HADACIDIN POTASS. NSC 72962

4Q2012

MFG & PROCESS DATA;MONITORS RESPONS. FOR CLIN. & PHARMACOLOG. DATA W 3361, A LIQUID ANTACID FORMULATION ---CHITOSAN ANTACID TYLOSIN; DIHYDROSTREPTOMYCIN; VIT. A & D ARE ACT. INGREDS. (VET MED) ADENOSINE-5' MONOPHOSPHATE (AMP) ---MFG PROCEDURE ACTINOGAN (NSC 54496 D) A649 (NSC 38270) GENERAL INFO DISCONTINUED INVESTIGATIONAL DRUGS GENERAL INFO DISCONTINUED INVESTIGATIONAL DRUGS MITOMYCIN C (NSC 26,980) VA INVESTIGATORS COMPANY'S PROCEDURES FOR TESTING NDA PRIOR TO SUBMITTING FOR APPROVAL GENERAL INFO--DISCONTINUED INVESTIGATIONAL DRUGS METHODS, FACILITIES AND CONTROLS

ABBOTT LABORATORIES PHARMACEUTICAL SPECTINOMYCIN (M-141, ABBOTT)(VET) PRODUCTS DIV ABBOTT LABS 2-(2-FORMYLHYDRAZINO)-4-(5-NITRO-2-FURYL)-THIAZOLE(AS-L7665)&A-2L203 DOW CHEMICAL CO MICHIGAN DIV NOT AN ASSIGNED NUMBER BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO ELANC0 DIV ELI LILLY & CO SOLVAY PHARMACEUTICALS CURRICULA VITAE OF CLINICAL INVESTIGATORS INVEST DRUG STREPTOMYCIN,TYLOSIN, ERYTHROMYCIN & PENICILLIN BOLUS(VET) GENERAL INFO-DISCN. INVESTIGATIONAL DRUGS PROPYLENE GLYCOL--TRADE NAME SIRLENE(VET)

Page 18

4Q2012EXCEL DMF# 635 636 637 638 639 640 641 I 642 643 644 645 646 647 I 648 649 650 651 652 653 654 655 656 657 658 659 660 661 662 663 664 665 666 I 667 668 669 670 671 672 673 N N I I I I I II II II II II 9/3/1963 9/12/1963 8/15/1963 8/15/1963 9/9/1963 I I I I I I I I I I I I I I I I I I II II V II III V V 9/10/1963 8/26/1963 9/4/1963 8/22/1963 8/22/1963 4/15/1963 9/9/1963 4/15/1963 4/22/1963 4/25/1963 4/11/1963 4/15/1963 4/15/1963 4/15/1963 5/27/1963 9/24/1963 4/15/1963 8/1/1963 8/27/1963 I I I I I II II II 8/27/1963 8/20/1963 1/1/1940 1/1/1940 8/27/1963 8/26/1963 STATUS Type SUBMIT DATE I I I N I I 7/22/1963 8/8/1963 7/19/1963 III II 8/16/1963 8/16/1963 8/15/1963 HOLDER JT BAKER CHEMICAL CO JT BAKER CHEMICAL CO FORT DODGE LABORATORIES NOT AN ASSIGNED NUMBER DORSEY LABORATORIES DIV SANDOZ INC HAMPSHIRE CHEMICAL CORP MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC FINE ORGANICS INC RT VANDERBILT CO UPJOHN CO CHEMAGRO CORP HOFFMANN LA ROCHE INC CREATIVE PACKAGING CO DIV ELI LILLY AND CO WARNER PACKAGING CORVEL, INC. KIRKHILL RUBBER CO MOORMAN MANUFACTURING CO. MOORMAN MANUFACTURING CO. PARKE DAVIS & CO VOCATIONAL REHABILITATION SERVICES PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO COMMERCIAL SOLVENTS CORP HESS AND CLARK CO DIV RICHARDSONMERRELL INC NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER CUDAHY PACKING CO PACIFIC NORTHWEST PRODUCTS, INC. INTERMOUNTAIN ELEVATOR CO. IMPERIAL PRE-MIX CO. ALBION VETERINARY SUPPLY SUBJECT DIETHYLPROPION CONTAINING TARTARIC ACID DIETHYLPROPION

4Q2012

P-234 (INJECT. ANTHELMINTIC IN SWINE) CALLED TRICHLORPHON & NEGUVON VASCULA (IS KNOWN IN GERMANY-USED TO IMPROVE PERIPHERAL CIRCULATION) HAMPSHIRE NTA NA3 (TRISODIUM NITRILOTRIACETATE MONOHYDRATE) 1-METHYL-1-(B-CHLOROETHYL) ETHYLENIMONIUM PICRYSULFONATE TEMASEPT II (TBS) (CHEM NAME-3,4'5 TRIBROMSALICYLANILIDE) VANGARD MB (MONOBENZONE) NSC-51173, (U-10955)--5A-ANDROSTAN-3-ONE,2A-FLUORO-17B-HYDROXY C0-RAL--0,0 DIETHYLO-3-CHLORO-4 METHYL-2-OXO-2H-1-BENZOPYRAN-7-YL LIBRIUM; TRANIMAL(VET) CONTRACT PACKAGING PACKAGING FACILITIES AND CONTROLS TYLOSIN 20MG PER CC AND NEOMYCIN 10MG PER CC (VET) KIRKHILL COMPOUND 270-A-905 AND 285-C-1156 RESEARCH EXPERIMENT # 1192 (VET) RESEARCH EXPERIMENT # 1167(VET) CLINICAL INVESTIGATION 461 PROCESSING--UNDER SUB-CONTRACTING ARRANGEMENTS FOR PHARMACEUT. FIRMS CLINICAL INVESTIGATION--CI-446 CLINICAL INVESTIGATION --CI 442 CLINICAL INVESTIGATION--CI423 CLINICAL INVESTIGATIONS--CI 400 AND 421 CLINICAL INVESTIGATION--CI 384 CLINICAL INVESTIGATION--CI 344 CLINICAL INVESTIGATION--CI-383 CLINICAL INVESTIGATION-- CI-395 CLINICAL INVESTIGATION--CI-499 (BUSCOPAN) CLINICAL INVESTIGATION--CI-462 COMBINATION-FEED GRADE ZINC BACITRACIN & DES IN CATTLE FEEDS (VET) NITROFURAZONE(VET)

DIETHYLSTILBESTROL MIX IN-CUDAHY 3% PHOSPHORUS MIXER W/DES 0.0088%(VET DIETHYLSTILBESTROL(VET) DIETHYLSTILBESTROL(VET) DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET) DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET)

Page 19

4Q2012EXCEL DMF# 674 675 676 I 677 678 679 680 681 682 683 684 685 686 687 688 689 I 690 691 I 692 693 694 695 696 697 698 699 700 701 I 702 703 704 705 706 707 708 709 I I I I I N I I II II II 6/16/1963 4/2/1963 10/24/1963 II II II 6/30/1961 1/21/1963 8/5/1963 10/16/1963 I I I I I I I I I II II II II II II V II 4/10/1963 10/2/1963 10/7/1963 10/11/1963 5/20/1963 3/11/1963 4/26/1963 4/19/1963 10/25/1963 8/30/1962 I V 10/1/1963 10/4/1963 I I I I I I I I I I I I V V II IV II II II II 9/27/1963 9/3/1963 8/26/1963 9/13/1963 8/26/1963 9/27/1963 8/5/1963 10/1/1963 9/24/1963 9/24/1963 8/27/1963 9/23/1963 10/3/1963 STATUS Type SUBMIT DATE A I IV II II 9/19/1963 9/26/1963 5/20/1963 HOLDER INTERNATIONAL SPECIALTY PRODUCTS NORWICH PHARMACAL CO STERLING-WINTHROP RES INST DIV STERLING DRUG INC SCHERING AG MERCK AND CO INC CORVEL, INC. MERCK AND CO INC CORVEL, INC. DOW CORNING CORP ARIZONA MILLING CO. CELANESE CORP GRAIN PROCESSING CORP GRAIN PROCESSING CORP HOFFMANN LA ROCHE INC UNION CARBIDE CORPORATION AMERICAN GASKET AND RUBBER CO DIV DART INDUSTRIES INC GRAIN PROCESSING CORP LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO ADRIA LABORATORIES DIV ERBAMONT INC ALBER MILLING CO. GEM FEED CO. ORGANON INC SALSBURY LABS ELANCO PRODS DIV ELI LILLY AND CO CHAS PFIZER AND CO INC ELANCO PRODS DIV ELI LILLY AND CO DOW CHEMICAL CO MICHIGAN DIV SUBJECT

4Q2012

GANTREZ AN (PVM/MA)-CHEM NAME:POLY(METHYL VINYL ETHER/MALEIC ANHYDRIDE VALSYN (FURALTADONE) WATER MIX(VET) STANOZOLOL (PYRAZOLE C 14), LABELLED (VET) SH-714 PRO-STREP CRUMBLES (VET) TYLOSIN & DIHYDROSTREPTOMYCIN (VET) AMPROL SUPER PLUS (AMPROLIUM & ETHOPABATE)(VET) TYLOSIN & NEOMYCIN USED AS AN EXPERIMENTAL PRODUCT(VET) SILICONE RUBBER DOW CORNING SILASTIC DIETHYLSTILBESTROL INTERMEDIATE PREMIXES --BEEF CATTLE FEEDS (VET) 1,3 BUTYLENE GLYCOL REQUEST TO MARKET EGGS OF PULLETS FED MANGANESE BACITRACIN(VET) REQUEST TO MARKET STEERS FED MANGANESE BACITRACIN(VET) CLEARANCE FOR SALE OF PPOULTRY, TREATED WITH SULFADIMETHOXINE(VET) UCONPROPELLANTS FORMULATION OF THE RUBBER COMPOUND USED BY RIKER LABS REQUEST TO MARKET TURKEYS FED MANGANESE BACITRACIN (VET) SULFAMETHAZINE LORAMINE SBU -185 (UNDECYLENIC ACID-MONOETHANOLAMIDE) MFG OF DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET) DIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET) PREPARATION OF CORTICOSTERONE FROM HYDROCORTISONE REQUEST AUTH. TO MARKET BROILERS FED NOVASTA(VET) VET. INVEST. DRUGS-TYLOSIN FOR BROILER HENS,BROOD SOWS & CATTLE(VET) COMPOUND P-3693A (VET) RS-1280 RESIDUALS IN LAYING CHICKENS(VET) ZOALENE W/ARSANILIC ACID OR SODIUM ARSANILATE IN MEDICATED FEED (VET)

ABBOTT LABORATORIES PHARMACEUTICAL ARSANILIC ACID--SODIUM ARSANILATE WITH ZOALENE (VET DMF) PRODUCTS DIV MERCK AND CO INC AMPROLIUM MEDICATED FEED -(3-NITRO-4-HYDROXYPHENYLARSONIC ACID) (VET) DORSEY LABORATORIES DIV SANDOZ INC ELANCO PRODS DIV ELI LILLY AND CO SALSBURY LABS NOT AN ASSIGNED NUMBER MERCK AND CO INC ER SQUIBB AND SONS INC AMPROLIUM IN CHICKENS(VET) MYCOSTAIN -20 IN PIGS (VET) TARPAN (HF/1984; HF/1931 HCL) CHLORMADINONE ACETATE PREMIX (VET)MADE PART OF DMF-699V NOVASTA-A FINISHED CHICKEN FEED(VET)

ABBOTT LABORATORIES PHARMACEUTICAL GALLIMYCIN (R)-10(ERYTHROMYCIN THIOCYANATE, ABBOTT) PRODUCTS DIV

Page 20

4Q2012EXCEL DMF# 710 I 711 712 713 714 715 716 I 717 718 719 720 721 722 I 723 724 725 726 727 728 729 730 731 732 733 734 I 735 736 737 I 738 739 740 I 741 742 I 743 744 745 I N A II 12/2/1963 V 11/1/1963 I II I 11/20/1963 11/29/1963 DOW CHEMICAL CO MICHIGAN DIV I I II V IV 11/15/1963 10/31/1963 11/26/1963 I I II II 10/14/1963 11/7/1963 11/18/1963 I I I I I I I I I I I II II II IV II II V II 7/11/1963 3/7/1963 12/10/1963 7/18/1963 8/8/1963 11/13/1963 11/4/1963 11/7/1963 8/6/1963 10/21/1963 11/14/1963 11/15/1963 NOVO NORDISK AS NATL INST HLTH NCI PUREX LABS JOHN W. ESHELMAN ELANCO PRODS DIV ELI LILLY AND CO BURROUGHS WELLCOME CO ELANCO PRODS DIV ELI LILLY AND CO ELANCO PRODS DIV ELI LILLY AND CO OZARK-MAHONING CO STATE OF UTAH, DEPT. OF FISH AND GAME LAKELAND CASH FEED CRYSTALLINE PORCINE TYPSIN, NOVO (FOR MFG,CONTROL SEE DMF-598) DRUG DEVELOPMENT PROGRAM DRAKEOL-ARLACEL RED ROSE SUPPLEMENTS AND CONCENTRATES (VET) TAPAZOLE AND DIETHYLSTILBESTROL FOR CATTLE (VET) CANOPAR BRAND THENIUM CLOSYLATE (VET) I A I A A II I IV IV II 11/4/1963 10/23/1963 10/28/1963 10/23/1963 11/5/1963 11/5/1963 I I I I I II II II II 8/15/1963 8/19/1963 10/11/1963 10/16/1963 10/8/1963 11/4/1963 STATUS Type SUBMIT DATE 10/16/1963 HOLDER CREATIVE PACKAGING CO DIV ELI LILLY AND CO CALIFORNIA CATTLE SUPPLY CO., INC. CAPITAL FEED AND SEED CO. STEPAN COMPANY OZARK-MAHONING CO OWENS ILLINOIS INC SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP SYNTEX SA STEPAN CO LILLY RES LABS DIV ELI LILLY CO STEPAN CO COLORCON INC SUBJECT CONTRACT PACKAGING OF FOOD & DRUG ADM. CONTROLLED PRODUCTS DIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET) DIETHYLENESTILBESTROL INTERMEDIATE PREMIXES (VET) LIPAL 9-LA (POLYOXYETHYLENE (9) LAURYL ETHER SODIUM FLUOROSTANNITES DISPOSABLE SYRINGE SKF 385 TRANYLCYPROMINE (VET) 6A-FLUORO-16A-METHYL DELTA 1,4-PREGNADIENE-11B,17A-DIOL-3,20-DIONE MCT (MEDIUM CHAIN TRIGLYCERIDES) PERSONNEL FILE: REQUIREMENTS FOR TECHNICAL & PROFESSIONAL STAFF WECOBEE BASES COLOR DISPERSIONS AND MIXED EXCIPIENTS

4Q2012

OHIO AGRICULTURAL EXPERIMENT STATION HESPERIDIN IN CATTLE (VET)

INVESTIGATIONS W/SWINE FED A COMBINATION OF TYLOSIN-STREPTOMYCIN (VET) STREPTOMYCIN-TYLOSIN-ERYTHROMYCIN-PENICILLIN COMBIN. ALONE & W/DES(VET STANNOUS FLUORIDE ENHEPTIN (2-AMINO-5 NITROTHIAZOLE) IN RAINBOW TROUT(VET) DIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET)

ABBOTT LABORATORIES PHARMACEUTICAL GALLIMYCIN-10(ERYTHROMYCIN,ABBOTT) & PRO-GEN (ARSANILIC ACID) (VET) PRODUCTS DIV ROMER AGRICULTURAL ENTERPRISES FEEDS CONTAINING DES(VET) PRO-VITA CO. SEARLE CHEMS INC SUB GD SEARLE AND CO GD SEARLE AND CO MOORMAN MFG. CO. KANSAS STATE UNIV. DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET) METRULEN,METRULEN-M,AND OVULEN --ETHYNODIOL DIACETATE S N-263, A SULFATED POLYSACCHARIDE (VET) RESEARCH EXPERIMENT #946(MOORMAN'S RID-EZY MINERAL BLOCKS) (VET) POLYOXYPROPYLENE,POLYOXYETHYLENE BLOCK POLYMER;SKF&WYANDOTTE EXP. (VET ZOALENE, AMPROLIUM PLUS-COMBINATION W/ARSANILIC ACID & GALLIMYCIN (VET

ABBOTT LABORATORIES PHARMACEUTICAL CURRICULUM VITAE OF ABBOTT'S THERAPEUTIC COMMITTEE PRODUCTS DIV AMERICAN CYANAMID CO APP TO EA POULTRY TREATED W/SULFACHLOROPYRAZINE FOR COCCIDIOSIS (VET) NOT AN ASSIGNED NUMBER CAMBREX PROFARMACO MILANO SRL CHLORIDAZEPOXIDE (KNOW IN ITALY AS METHAMINODIAZEPOXIDE)

Page 21

4Q2012EXCEL DMF# 746 747 748 749 I 750 751 752 753 754 755 756 757 758 759 760 761 762 763 I 764 765 766 767 768 769 770 771 772 773 774 I 775 776 777 778 779 I 780 781 782 783 I A I I III IV I 2/7/1964 2/5/1964 2/5/1964 2/12/1964 I I I I I II II II 9/30/1963 1/17/1964 1/21/1964 1/24/1964 2/6/1964 I I I I I I I I I N II 1/14/1964 II II II II II II 1/7/1964 10/8/1963 12/12/1963 12/19/1963 1/10/1964 1/16/1964 1/21/1963 1/15/1964 6/21/1963 I I I I I I I I I I I I I I II II II II II I II II II II II 12/11/1963 12/26/1963 12/3/1963 12/6/1963 12/6/1963 12/6/1963 12/3/1963 12/9/1963 12/16/1963 1/6/1964 12/23/1963 1/9/1964 12/31/1963 12/24/1963 STATUS Type SUBMIT DATE I I I II II II 11/6/1963 11/12/1963 12/10/1963 11/22/1955 HOLDER WITHMORE FEEDS INC DOW CHEMICAL CO MICHIGAN DIV AJINOMOTO CO INC SUBJECT

4Q2012

TEREPHTHALIC ACID PLUS CHLORTETRACYCLINE-INVEST. PROGRAM IN FEED (VET) ZOAMIX AND ERYTHROMYCIN THIOCYANATE(VET) L-ARGININE MONOHYDROCHLORIDE

MERCK CHEM MANUFACTURING DIV MERCK DIETHYLSTILBESTROLTRADE NAME:RUMESTROL 1 AND 2(VET) & CO INC THOMPSON HAYWARD CHEMICAL CO MFGR OF DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET) MILBUR-ELLIS CO./TX AMERICAN HOME PRODUCTS AMERICAN HOME PRODUCTS AMERICAN HOME PRODUCTS AMERICAN HOME PRODUCTS AMERICAN HOME PRODUCTS AMERICAN HOME PRODUCTS ORGANON INC UPJOHN CO MERCK SHARP & DOHME RESEARCH LABS ALCON LABORATORIES INC CHEMETRON CHEMS DIV CHEMETRON CORP PRONTO ADDRESSING AND MAILING SERVICE INC CUSTOM PACKAGING IOWA STATE UNIV. NORTH CAROLINA STATE ARLIN CHEMICALS INC RM HOLLINGSHEAD CORP SOUTHWEST FLOUR AND FEED CO. CONSUMERS COOPERATIVE ASSOCIATION CHAS PFIZER AND CO INC PARKE DAVIS & CO NOT AN ASSIGNED NUMBER HESS AND CLARK CO DIV RICHARDSONMERRELL INC THE FARR COMPANY CHEMAGRO CORP STUART DIV ATLAS CHEM INDS INC-ORIG GANES CHEMICALS INC USE OF FURAZOLIDONE TO MEDICATE DUCKS(VET) DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET) BAYER 9002 (BAYER S-940)(VET) VITAMINS B-6, B-12--INTRINSIC FACTOR CONCENTRATE TABLETS CALCIUM PHENOBARBITAL DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET) INJECTABLE NOLVASAN(VET) TRICHLORFON IN SWINE (INJECTABLE) (VET)--ADD. CORRES. TO DMF-637 TENIACIDE IN DOGS, MICE AND CAS(VET) P-223 HORSE ANTHELMINTIC(VET) RENACIDEN IN DOGS AND CAS(VET) DYREX INJECTABLE IN SWINE AND HORSES(VET) PREDNISOLONE SODIUM PHOSPHATE PROMONE(MEDROXYPROGESTERONE ACETATE(VET) PRO-STREP IN SWINE(VET) DAROIL INVESTIGATORS FACILITIES, PERSONNEL & CONTROLS PROCEDURES MEDICAL ADDRESSING AMD MAILING SERVICE PACKAGING OF WALLACE LABS--ETHICAL PRODUCTS ARSANILIC ACID(VET) LACTOSTA FOR EXPERIMENTAL PURPOSES-PERMISSION TO RECIEVE (VET) MECLIZINE HCL QUATERNARY AMMONIUM SACCHARINATES DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET) DIETHYLSTILBESTROL INTERMEDIATE PREMIXES-STILBOSOL(VET) POLYMYXIN METHANE SULFONATE FOR TREA. OF DISEASE IN POULTRY(VET) VIRAL AND BACTERIAL VACCINE

GEIGY PHARMACEUTICALS DIV CIBA GEIGY SPECIFICATIONS AND TEST METHODS FOR INERT INGREDS. CORP RHONE POULENC INC METRONIDAZOLE PLASTICOID CO FELTON WORLDWIDE INC SYNTEX SA RUBBER FORMULATIONS FELCOFIX IMITATION WILD STRAWBERRY FLAVOR T.F. #1347 GENERAL MASTER FILE --SPECIFICATIONS

Page 22

4Q2012EXCEL DMF# 784 785 786 787 I 788 789 790 791 792 793 794 795 I 796 797 I 798 799 I 800 801 802 803 804 805 806 807 I 808 809 I 810 811 812 I 813 814 815 816 817 818 819 I N N N N N A IV 10/23/1962 9/2/1964 I I II 6/8/1964 6/15/1964 6/16/1964 I 3/17/1964 6/2/1964 A I I A I A A III II I II IV 5/7/1964 1/20/1964 5/19/1964 5/13/1964 1/22/1964 5/15/1964 5/20/1964 6/1/1964 I III IV 5/8/1964 5/11/1964 I 5/6/1964 5/7/1964 I I I I N I I II 3/18/1964 4/10/1964 4/17/1964 II 2/24/1964 2/28/1964 3/2/1964 2/12/1964 STATUS Type SUBMIT DATE I I I 1/21/1964 2/18/1964 2/24/1964 2/18/1964 HOLDER PRINCETON LAB PRODS CO RHODIA INC PRECISION PACKAGING COMPANY INC WM S MERRELL CO DIV RICHARDSONMERRELL INC-ORIG ROBINSON WAGNER COMPANY INC SYNTEX SA SYNTEX SA COLUMBIA UNIV NOT AN ASSIGNED NUMBER DOW CHEMICAL CO MICHIGAN DIV PITMAN-MOORE CO DIV DOW CHEM CO DOWEX 1 X 2 RESIN --FACILS & CONTROLS METHODS AND CONTROLS SUBJECT PREPARATION & PURIFICATION OF ACTH FROM HOG PITUITARY GLANDS

4Q2012

PROPERICIAZINE-3-CYANO-10-(3'(4-HYDROXY PIPERIDINO PROPYL)PHENOTHIAZI PACKAGING FACILITIES AND CONTROLS CONTROLS AND FACILITIES LANOLIN DERIVAIVES FLUMETHASONE PARAMETHASONE PHOSPHATE DISODIUM SALT MULTIDOSE JET INJECTION DEVICE --INVESTIGATIONAL USE

DON SPARKS ASSOCIATES DIV L GORDON & CUSTOM PACKAGING OF TABLETED OR CAPSULATED MEDICATION SON INC JENSON HJ ADENYLIC ACID VICTOR M HERMELIN CO DIV K-V PHARMACAL CO UNETTE CORP DISTILLATION PROD INDS DIV EASTMAN KODAK CO CREMER OLEO GMBH AND CO KG HENKEL KGAA LILLY RES LABS DIV ELI LILLY CO SPI PHARMA INC NATL INST HLTH NCI SPENCER CHEMICAL CO DR REDDYS LABORATORIES LTD DISTILLATION PROD INDS DIV EASTMAN KODAK CO PACINI AUGUST J MD MEPROBAMATE 400MG AND 200MG PROLONGED RELEASE CAPS CUSTOM PACKAGING OF DRUG AND PHARMACEUTICAL PRODUCTS PINACYANOLE CHLORIDE MIGLYOL 812 AND 810 MANUFACTURED IN WITTEN, GERMANY. EUTANOL G; SUPPOS. BASE I & II; SUPPOS. G. CETIOL & TOXAPON CS PASTE MONITORS--CLINICAL INVESTIGATORS MANNITOL MANUFACTURED IN NEW CASTLE ,DELEAWARE DIMETHYL SULFOXIDE POLY-ETH POLYETHYLENE RESIN 1099 FLUOCINOLONE ACETONIDE ACETATE MFG IN MEXICO AND THE BAHAMAS 2,6 DICHLOROINDOPHENOL SODIUM SALT ALOE VERA ACTIVE PRINCIPLE

MERCK CHEM MANUFACTURING DIV MERCK MANUFACTURING AND CONTROL FACILITIES A RAHWAY, NJ & CO INC PHARMACHEM CORP MFGR OF LOW MOLECULAR WEIGHT DEXTRAN POWDER SYNTEX SA WADLEY INSTITUTES OF MOLECULAR MEDICINE HEWITT SOAP COMPANY INC NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER FIRMENICH INC FLAVOR FORMULAS MFGR CONTROLS-50% CHLORMADINONE ACETATE TRITURATION IN LACTOSE USP INFORMATION $ METHODS DETERGENT CLEANSING BAR

Page 23

4Q2012EXCEL DMF# 820 821 I 822 823 824 825 826 827 828 829 830 831 832 833 834 835 836 837 838 839 840 841 842 843 844 845 846 847 848 849 850 851 852 I 853 854 855 856 I 857 858 I I I 11/5/1964 11/10/1964 I I I IV III 11/23/1964 11/5/1964 11/19/1964 12/15/1964 I I I I I I I I I A I I I I I I I I I I I N N I I I I I I I II 9/30/1964 10/6/1964 10/1/1964 10/15/1964 6/30/1964 10/28/1964 10/30/1964 11/25/1964 IV IV II IV IV II II IV III I II II 7/2/1964 7/2/1964 7/21/1964 6/25/1964 6/3/1963 9/9/1964 8/11/1964 9/3/1964 8/27/1964 8/21/1964 8/19/1964 8/7/1964 8/13/1964 9/9/1964 9/14/1964 9/14/1964 9/16/1964 9/14/1964 9/3/1964 8/28/1964 8/10/1964 STATUS Type SUBMIT DATE I 6/26/1964 6/19/1964 HOLDER CLORO-BAC PRODS INC SUBJECT

4Q2012

CHLORINE DIOXIDE; CHLORODOXINE X-2;AQUA-SAN CHLORINE DIOXIDE FORMULA.

ABBOTT LABORATORIES PHARMACEUTICAL ANTIBIOTIC M-188(MACROLIDE ANTIBIOTIC OF THE ERYTHROMYCIN GROUP) PRODUCTS DIV NYSCO LABS INC PAPAVERINE HCL-TIME RELEASE PELLETS (BULK) NYSCO LABS INC NYSCO LABS INC STEPAN COMPANY SILGAN PLASTICS CORP PARKE DAVIS DIV WARNER LAMBERT CO RP SCHERER CORP FEDERAL MAILING AND PACKAGING NYSCO LABS INC SANOFI CHIMIE RHONE-POULENC REYNAUD LTD SCHUTZ & CO SOLVAY DUPHAR BV STEPAN COMPANY STEPAN COMPANY LAWSON PACKAGING CORP JT BAKER CHEMICAL CO HENKEL KGAA STEPAN COMPANY HENKEL KGAA NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER PFIZER LABS DIV CHAS PFIZER AND CO INC ALTHIAZIDE INTERNATL CHEM & NUCLEAR PHARMS INC DRAGOCO INC EI DUPONT DE NEMOURS AND CO CHEMIRAD CORP MEADE THOMAS J WYANDOTTE CHEMS CORP-ORIG CHROMIUM-51 (HIGH SPECIFIC ACTIVITY ISOTOPE) PUR-CELLIN OIL, DRAGOCO SCIENTIFIC PERSONNEL TRIETHYLENE MELAMINETEM MARIV 240 (HIGH IODINE VALUE FISH OIL FRACT.)-S. AFRICAN PILCHARD OIL URETHANE LATEX E-204 DEXTROMETHORPHAN HYDROBROMIDE (IN BULK TIME RELEASE PELLETIZED FORM) METH & FACIL-T.R. CAP W/DEXTROMETHORPHAN,CHLORPHENIRAMINE&PHENYLEPHRIN POLYGLYCEROLS & ESTERS OF FATY ACIDS HIGH & LOW DENSITY POLYETHYLENE EPOXY RESIN FROMULATION #LA-16 METHODS, FACILS & CONTRLS HARDSHELL GELATIN CAPS METHODS, FACILITIES AND CONTROLS PAPAVERINE HCL-METHODS, FACIL,CONTRL-IN MFGR OF T.R. CAPS TRIMEPRIMINE(TRIMIPRAMINE-USAN) METHODS FACILS & CONTROLS --REGARDING MFGR OF RP 8599 COUGH SYRUP FLAVOR R 446 MESO-INOSITOL HEXANICOTINATE LACTULOSE SOLUTION VEGETABLE OIL 1400 NEOBEE O HANDLING & PACKAGING OF DRUG PRODS IN PHARMACEUTICAL PROGRAMS ETHYL DIBUNATE (PRODUCTION) DEPLASTOL AR 13026 AND AR 13027 NASUNA A AND NASUNA B

ABBOTT LABORATORIES PHARMACEUTICAL IRON-58 STERILE SOLUTION PRODUCTS DIV JT BAKER CHEMICAL CO CHLOROTRIANISENE HOSPIRA ASHLAND PARKE DAVIS & CO COLONIAL SUGARS COMPANY SUCRO CHEMICAL DIV JT BAKER CHEMICAL CO 3M PHARMS FAULTLESS COMPOUNDS PROCEDURES SUCROSE MONOPALMITATE AZACYCLONOL HCL MANUFACTURING AND CONTROL FACILITIES AND PERSONNEL

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4Q2012EXCEL DMF# 859 860 861 862 863 864 865 866 867 868 869 870 871 872 873 874 875 876 877 I 878 879 880 881 882 883 884 885 A 886 887 888 889 890 891 892 893 894 895 896 I 897 I IV 6/9/1965 I I I I I I I I I I II IV I 4/19/1965 4/19/1965 4/29/1965 5/6/1965 5/6/1965 5/6/1965 5/12/1965 5/13/1965 5/17/1965 6/1/1965 6/10/1965 I A I A I A I III II II III 3/2/1965 3/15/1965 3/5/1965 1/2/1965 3/8/1965 3/18/1965 3/31/1965 3/29/1965 STATUS Type SUBMIT DATE I I I I A I N I I I I I N I I I I I II 1/7/1965 2/15/1965 1/15/1990 9/24/1964 2/26/1965 2/24/1965 II II 12/2/1964 12/22/1964 1/14/1965 1/14/1965 1/5/1965 II II 12/10/1964 6/26/1967 12/22/1964 12/16/1964 11/23/1964 12/21/1964 HOLDER WORTHINGTON BIOCHEM CORP SCHUYLKILL CHEM CO VAN DYK AND CO INC WHEATON SCIENTIFIC ARCH CHEMICALS INC PILLSBURY CO NOT AN ASSIGNED NUMBER CHRISTIAN BRUNNENGRABER AND CO SYNTEX SA SYNTEX SA FINE ORGANICS INC ROHM AND HAAS CO NOT AN ASSIGNED NUMBER SCHIEFFELIN AND CO PFISTER CHEMICAL COMPANY INC STOCKHOLMS GUMMIINDUSTRI AB GARRETT LABS INC MYERS-CARTER LABS INC FACILS, MFG, PROCESSING AND PACKAGING FLUOROPHENE RUBBER STOPPERS QUALITY 2213 BACITRACIN AEROSOL SPRAY FACILS., CONTROLS AND PERSONNEL & PROCEDS. METHOCARBAMOL FLUMETHASONE FLUMETHASONE ACETATE TEMASEPT III RHOZYME 41 CONCENTRATE SUBJECT BETA LIVER FRACTION -B ALLANTOIN AND THE ALUMINUM ALLANTOINATES CERAPHYL 28 (CETYL LACTATE) GLASS MANUF. PROCEDURES ZINC OMADINE MANUFACTURED IN ROCHESTER NY POLYTETRAN (BRAND OF BETA-GLUCAN)

4Q2012

PHILADELPHIA LABS INC DIV PHILA PHARMS MANUFACTURING AND CONTROL FOR PRODUCTION OF MEPROBAMATE AND COSMETICS INC DAY BALDWIN INC FACILITIES AND PERSONNEL TOMPKINS PHARMACEUTICAL RUBBER PACKAGING COMPONENTS INC CAMBREX PROFARMACO MILANO SRL BF GOODRICH COMPANY CAMBREX PROFARMACO MILANO SRL US PUBLIC HEALTH SERV EQUISTAR CHEMICALS LP SUB LYONDELLBASELL INOLEX CHEMICAL CO CROWN ZELLERBACH CORP NYSCO LABS INC SHELL CHEM CO SHELL CHEM CO SHELL CHEM CO RHODIA INC ER SQUIBB AND SONS INC NYSCO LABS INC GEIGY CHEM CORP VICTOR M HERMELIN CO DIV K-V PHARMACAL CO HENKEL KGAA RUBBER FORMULATIONS METHODS, CONTROLS AND FACILITIES HYDROCHLOROTHIAZIDE MANUFACTURED IN MILAN, ITALY. CARBOSET RESINS CHLOROTHIAZIDE INVESTIGATOR INFO POLYMERS FOR USE IN PACKAGING METHODS, FACILS & CONTROLS DIMETHYL SULFOXIDE(DMSO)FACILITIES AND CONTROLS FACILITIES AND CONTROLS HUMAN STUDIES FOR NEW DRUGS INVESTIGATORS FOR HUMAN STUDIES FACILITIES-GENERAL MFGR PROTOCOL AND RAW MATERIAL CONTROLS RP 9965 SILICONE FLUIDS DIPHENHYDRAMINE HCL -PELLETS IRGASAN CH 3549 PETN - BUTABARBITAL DEHYMULS E AND DEHYMULS K

Page 25

4Q2012EXCEL DMF# 898 899 900 901 902 903 I 904 905 906 907 908 909 910 911 912 I 913 914 915 916 917 918 I 919 920 921 922 923 924 925 926 927 928 I 929 930 931 932 933 934 I I I A I I III IV II II I 12/9/1965 12/3/1965 12/15/1965 12/16/1965 12/27/1965 12/8/1965 PCM CORP CUSTOM PACKAGING HOSPIRA INC WR GRACE ELI LILLY AND CO I I I I I I I I I II I 11/9/1965 11/17/1965 11/13/1965 11/15/1965 11/23/1965 11/30/1965 11/24/1965 12/8/1965 12/8/1965 12/9/1965 I I I A I V II 9/7/1965 9/15/1965 9/10/1965 9/24/1965 9/24/1965 10/11/1965 I I I I I I I I II IV IV 8/24/1965 8/23/1965 8/23/1965 8/25/1965 8/28/1965 9/2/1965 9/2/1965 9/2/1965 7/6/1965 STATUS Type SUBMIT DATE I I I I I III II 6/9/1965 6/24/1965 7/19/1965 7/22/1965 7/29/1965 8/13/1965 HOLDER MILAN PHARMACEUTICALS INC MURRAY RODERICK MD AMERICAN NATIONAL CAN CO ORGANON INC P-L BIOCHEMS INC WALLACE LABORATORIES DIV CARTER WALLACE INC DOW CHEMICAL CO MICHIGAN DIV GD SEARLE AND CO HENKEL KGAA PACIFIC BIOCHEM INC SYNTEX SA UNGERER AND CO CONNAUGHT MED RES LABS JUNICE LABS INC FIRST TEXAS PHARMACEUTICALS INC SUB SCHERER LABS INC JUNICE LABS INC PHARMA-RES CANADA LTD KLINE NATHAN S MD CIBA CORP CROWN ZELLERBACH CORP WINTHROP PHARMACEUTICALS DIV STERLING DRUG INC PARKE DAVIS & CO STIEFEL LABORATORIES INC CARRON PRODUCTS CO SB PENICK AND CO ORIG OWENS ILLINOIS INC BROCKWAY GLASS CO INC EJ TRUM INC NORTON CO EURAND AMERICA INC BOEHRINGER MANNHEIM GMBH SUBJECT MEPROBAMATE TABLETS IND LISTING DIV. OF BIOLOGICS STANDARDS POLYOLEFIN PRODUCTS (C-70 SERIES) MESTRANOL DIPHOSPHOPYRIDINE NUCLEOTIDE (DPN) MEPROBAMATE POWDER-WITH TRACER TEFLURANE METHODS, FACILITIES & CONTROLS DEHYDAG-PRODUCTS1. DEHYDAG WAX O METHODS & FACILITIES DIMETHISTERONE COMPOUND FLAVOR #5218 PHENOXALID(COMPOUND #377) PROMETHAZINE HYDROCHLORIDE U.S.P. (MANUF. & SPECIFICATIONS) MANUFACTUER PROCEDURES CHLORPROMAZINE HYDROCHLORIDE U.S.P. FLOOR PLAN ---- EQUIPMENT ---- PERSONNEL RESEARCH INFORMATION TRICLOSAN TOXICOLOGY INFORMATION TRICHLOROLEVULINIC ACID (TCLA) IN POLYETHYLENE LINED CONTAINERS COMPOUND 904 GYNECOLOGY BOOK SULFOXYL 342 RED NATURAL RUBBER COMPOUNDS AND P & H COATING QUERCETIN

4Q2012

PROJECT NO. 84258 EXTRACTION STUDIES FROM TIN OXIDE COATED BOTTLES THE CHEMICAL DURABILITY OF F-GLASS PACKAGING CARTON MANUFACTURING MAILING HISTORY AND PROCEDURES ENCAPSULATION MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. PACKAGING METHODS AND FACILITIES OPERATION AND PROCEDURE PLIA-LITER (TM) BAGS SYLOID - SILICA PRODUCTS (SILICA GEL) AMPOULES SODIUM THIOCYANATE, INJECTION COMPOUND #23206

AYERST LABORATORIES INC DIV AMERICAN PREMARIN (CONJUGATED ESTROGENS-EQUINE) HOME PRODUCTS CORP

Page 26

4Q2012EXCEL DMF# 935 936 937 938 939 940 941 942 I 943 944 I 945 946 947 948 949 950 951 952 953 954 955 956 957 958 959 960 961 962 963 I 964 965 966 967 968 969 970 971 972 973 I I I A I I I I I I I IV II 5/13/1966 6/7/1966 6/6/1966 12/21/1965 6/20/1966 6/22/1966 6/23/1966 6/27/1966 6/27/1966 6/22/1966 SCHERING AG NORTH AMERICAN PHILIPS CO INC MILES PHARMACEUTICAL DIV MILES INC COLORCON INC DAVIS-EDWARDS PHARMACAL CORP ER SQUIBB AND SONS INC DOW CORNING CORP AMERICAN CYANAMID CO ARMOUR PHARMACEUTICAL CO HENKEL KGAA MESTRANOL MEBEVERINE HYDROCHLORIDE CURRICULUM VITAE (PERSONNEL) POLYVINYL ACETATE PHTHALATE METHODS, FACILITIES, CONTROLS AND PACKAGING OF DRUGS I I I I I I I A I I I I I I I I I I I I III III IV 3/11/1966 10/28/1965 2/2/1966 3/16/1966 3/18/1966 3/15/1966 3/30/1966 4/6/1966 4/1/1966 1/6/1966 4/19/1966 4/19/1966 4/22/1966 4/26/1966 5/6/1966 5/11/1966 5/11/1966 5/13/1966 5/5/1966 I 2/28/1966 2/25/1966 HENKEL KGAA WARNER LAMBERT CO PHARMACEUTICAL RESEARCH DIVISION HUMBLE OIL AND REFINING CO GUARDIAN CHEMICAL CORP STANDARD AROMATICS INC ROBIN PHARMACAL CORP-ORIG DOW CHEMICAL CO MICHIGAN DIV CF BOEHRING AND SOEHNE GMBH RHODIA INC KLOCKNER PENTAPLAST OF AMERICA INC CP HALL CO NATL INST HLTH CLINCL CTR PHARMACY FISONS PHARM LTD TRI X CORP ER SQUIBB AND SONS INC SYNTEX (USA) INC GANES CHEMICALS INC JT BAKER CHEMICAL CO FISHER STEVENS INTRA PRODS DIV DURR PRODS STATUS Type SUBMIT DATE I I I I I I I I I III 1/11/1966 1/26/1966 2/1/1966 2/4/1966 2/11/1966 2/21/1966 2/17/1966 2/28/1966 HOLDER FINE ORGANICS INC BERLIN LABS INC TUBED CHEMICALS CORP EI DUPONT DE NEMOURS AND CO DIAMOND ALKALI CO VYPAK CORP CLARK ONIELL INC ARMSTRONG LABORATORIES INC SUBJECT TEMASEPT IV DMSO INFORMATION FACILITIES & CONTROLS

4Q2012

POLYETHYLENE FILM TYPE A-101 (DRUG PACKAGING) AND MYLAR POLYESTER FILM CP 519-2 POLYVINYL CHLORIDE RESINPOLYVINYL CHLORIDE RESIN, CP 519-2 P-2, P-6 & P-7 POLYVINYL CHLORIDE COMPOUNDS ASSEMBLING AND MAILING OF DRUG SAMPLE AND LITERAURE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WEST ROXBURY, MASSACHUSETTS. PRESERVAIVE C INVESTIGATIONAL NEWN DRUG LISTINGS ISOPAR SURTENOL IMITATION FLAVOR MANUFACTURING AND PROCEDURES ETHOXYLATED POLYETHYLENIMINE, MONTREK600E NICOTINAMIDE-ADENINE-DINUCLEOTIDENADDPN CLOREXOLONE GENOTHERM TYPE PVC FILMS PARAPLEX G-50(THIS DFORMERLY HELD BY ROHM AND HAAS CO) LISTING ----DIV BIOLOGICS NOTICES (IND'S) LOMODEX (DEXTRAN 40 INJECTION) FACILITIES AND CONTROLS FACILITIES AND CONTROLSPERSONNEL FOR MANUFACTURE AND CONTROL FACILITIES AND CONTROLS EBNZOMETHAMINE CHLORIDE CLOMIPHENE CITRATE DESCRIPTION OF FACILITIESPROCEDURESCONTROLSPERSONNEL CONTROLS AND FACILITIES

CALGON CORP DIV MERCK & COMPANY INC BIOCHEK 60

SUMMARIES OF THE BACKGROUND & QUALIFICATION OF INVEST & MONITORS DOW CORNING (R) 555 FLUID CYTOX (R) 2013 DODECYLGUANIDINE HYDROCHLORIDE LYOSZYME TEXAMID S 058 AND CUTINA OR

Page 27

4Q2012EXCEL DMF# 974 975 976 977 978 I 979 980 981 982 983 984 985 986 987 988 989 990 991 992 993 994 995 I 996 997 998 999 1000 1001 1002 1003 1004 1005 I 1006 1007 1008 1009 1010 1011 1012 I I A I I I I III II 11/4/1966 11/1/1966 10/31/1966 11/10/1966 5/20/1965 11/21/1966 11/18/1966 I I I I I I I I I II V I I 8/22/1966 9/20/1966 9/21/1966 9/14/1966 9/15/1966 9/16/1966 10/13/1966 10/19/1966 10/21/1966 10/28/1966 I I I I I I I I I I A I I N I I III 9/15/1966 9/22/1966 9/7/1966 I V III I III II III I III IV 7/12/1966 7/16/1966 7/22/1966 7/25/1966 8/1/1966 8/10/1966 8/15/1966 8/29/1966 2/11/1966 9/14/1966 8/25/1966 10/1/1966 9/3/1966 STATUS Type SUBMIT DATE I I I A II II III II 6/28/1966 7/6/1966 7/11/1966 7/1/1966 7/13/1966 HOLDER SHELTERED EMPLOYMENT SERVICES INC RHODIA INC ATOMIC ENERGY OF CANADA LTD BAXTER HEALTHCARE CORP VICTOR M HERMELIN CO DIV K-V PHARMACAL CO HELVOET PHARMA SHIONOGI QUALICAPS INC LABORATORIES GLAXO EVANS MARION LABORATORIES INC PHARMACIA FINE CHEMS REYNOLDS PACKAGING LLC NYSCO LABS INC VCF PACKAGING FILMS INC SERUMWERK BASEL AG ALCON LABORATORIES INC HOSPIRA HOFFMANN LA ROCHE INC HOFFMANN LA ROCHE INC NOT AN ASSIGNED NUMBER BECTON DICKINSON AND CO HENKEL KGAA IVERS-LEE MIDWEST CO INC DIV BECTONDICKINSON AND CO HENKEL KGAA LEMMON CO MALLINCKRODT INC EJ TRUM INC GENERAL FOODS CORP SLOAN-KETTERING INST CANCER RES NYSCO LABS INC NYSCO LABS INC TROPONWERKE GMBH CO KG SCHERING CORP SUB SCHERING PLOUGH CORP NYSCO LABS INC HOFFMANN LA ROCHE INC HENKEL CORP BARR-STALFORT DIV PITTWAY CORP COLONIAL SUGAR REFINING CO LTD HENKEL KGAA DRUG & ALLIED PRODUCTS GUILD INC PARENTOPAK PHARMACEUTICAL SYRINGE EDENOL BS (STEARIC ACID BUTYL ESTER) PACKAGING FACILITIES AND CONTROLS LUBRICANTS FOR PLASTICS FACILITIES, EQUIPMENT AND CONTROLS FACILITIES, PROCEDURES AND PERSONNEL FACILITIES AND CONTROLS MONSODIUM DIHYDROGEN PHOSPHATE CLINICAL INVESTIGATORS FILE. PSEUDOEPHEDRINE HCL TIMED RELEASE PELLETS PHENOBARBITAL TIMED RELEASE PELLETS METHAQUALONE BASE AND HCL THIHEXINOL METHYLBROMIDE PAVABID-PB TIMED RELEASE CAPSULES COMPOSITION & MFGR OF INJECTABLE SOLUTION OF HEPARINOID RO 1-8307 GELVA? MULTIPOLYMER RESIN EMULSIONS (GME) AEROSOL PRODUCTION OPERATIONS CLINICAL TESTING OF ANTI-CARIES AGENTS FATY ACIDS EFFECTIVENESS OF ANTIBIOTIC DRUGS SUBJECT FACILITIES, CONTROLS AND PROCEDURES PENTAMIDINE ISETHIONATE RADIOISOTOPE MASTER FILE POLYVINYL CHLORIDE PLASTIC (PL-146) NITROGLYCERIN FORMULAS AND INGREDIENTS FORMULA INDENTIFICATION CODE--IDENTI-CODE INDEX CARRAGRRIN DERIVAIVE C.16 FACILITIES AND CONTROLS DEAE-SEPHADEX (C-800 074) FOIL-VINYL SPECIFICATION BROMODIPHENHYDRAMINE HYDROCHLORIDE CAST VINYL FILMS C-102 & C-105 FORMERLY HELD BY CADILLAC PLASTIC) TOQUILONE COMPOSITUM FACILITIES AND CONTROLS STERILE MANUFACTURING FACILITY IN CLAYTON NC PACKAGING MATERIALS RAW MATERIAL

4Q2012

Page 28

4Q2012EXCEL DMF# 1013 1014 1015 1016 1017 1018 1019 I 1020 1021 1022 1023 1024 1025 1026 1027 1028 1029 1030 1031 1032 1033 1034 1035 1036 1037 1038 1039 1040 1041 1042 1043 1044 I 1045 1046 1047 1048 1049 1050 1051 I I I I A A A III II II II II 3/28/1967 3/27/1967 3/31/1967 3/24/1967 3/21/1967 3/22/1967 3/23/1967 I I I A I I I I I I I I I I I I I I I I I I I I II II II 3/9/1967 3/7/1967 3/15/1967 3/17/1967 3/27/1967 3/29/1967 II II III II 1/13/1967 1/12/1967 1/19/1967 1/16/1967 12/6/1966 1/31/1967 2/1/1967 2/2/1967 2/6/1967 2/6/1967 2/6/1967 2/6/1967 2/9/1967 3/10/1966 2/16/1967 2/16/1967 2/2/1967 3/1/1967 STATUS Type SUBMIT DATE I I I A I I IV II III 12/13/1966 12/14/1966 12/2/1966 12/14/1966 12/22/1966 1/5/1967 1/5/1967 HOLDER DOWNINGTON PAPER CO ER SQUIBB AND SONS INC SCHERING AG CHEVRON PHILLIPS CHEMICAL CO LP GENERAL ANILINE AND FILM CORP ICI AMERICAS INC SUBJECT PROCEDURE FOR CONTRACT PACKAGING OF DRUGS PATIENT STARTER PACKAGES AMIDOTRIZOIC ACID(UROGRAFIN ACID) MARLEX RESINS-POLYOLEFINS FOR DRUG PACKAGING USE UVINUL N-539 PGAC-112(THIS DFORMERLY HELD BY CHATEM CHEMICALS)

4Q2012

CIBA PHARMACEUTICAL CO DIV CIBA GEIGY ORISUL TABS, SUSPENSION & SUSPENSION FOR CHILDREN CORP GEIGY CO SA FACILITIES AND PERSONNEL CONTROL OPERATIONS,MANUFACTURING OPERATIONS NYSCO LABS INC CHAS PFIZER AND CO INC OXYVINYLS LP MURRAY E CORN ASSOC INC VPI MIRREX CORP ICI AMERICAS INC GENERAL ATOMIC FLUORITAB CORP FLUORITAB CORP FLUORITAB CORP P-L BIOCHEMS INC MICRO CHEMS LTD ER SQUIBB AND SONS INC KAROLINSKA INST CHATTEM DRUG & CHEMICAL COMPANY PARKE DAVIS & CO HOFFMANN LA ROCHE INC UNKNOWN NAFTONE INC ATLAS CHEMICAL INDUSTRIES INC VALE CHEMICAL COMPANY INC MONSANTO COMPANY OLIN MATHIESON CHEM CORP LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO FINE ORGANICS INC PHILLIPS PETROLEUM CO LILLY RESEARCH LABORATORIES GANES CHEMICALS INC SIEGFRIED USA LLC SIEGFRIED USA LLC SIEGFRIED USA LLC 6-AMINOCAPROIC ACID STANDARD DRUG MIXTURE NO. 16 (10% NITROGLYCERIN-LACTOSE MIXTURE) FACILITIES, METHODS AND PERSONNEL POLYVINYL CHLORIDE CONTAINERS SODIUM OMADINE SPECTRASORB UV 531 ALLANTOIN MARLEX 0202 POLYOLEFIN RESIN POLYVINYL CHLORIDE CONTAINERS BUTABARBITAL PHENOBARBITAL SECOBARBITAL SODIUM USP AMOBARBITAL ISOSORBIDE DINITRATE TIMED RELEASE PELLETS METAMINE POLYVINYL CHLORIDE TETRACYCLINE HCL S.R. RP 16,091 (10-METHYL-2-PHENOTHIAZINYL) ACETIC ACID STANDARD DRUG MIXTURE NO. 23 (20% PETN) ISOTOPE RESEARCH PROGRAM DURABONE #5 TABLETS (11.25MG. SODIUMFLUORIDE) DURABONE #10 (22.5MG SODIUM FLUORIDE) TABLETS DURABONE # 25 (56.25MG SODIUM FLUORIDE) TABLETS TRIFLUOROTHYMIDINE (F3TDR), FACILITIES AND CONTROLS MEPROBAMATE N.F. LISTING OF INDS CHOLECYSTOKININ-PANCREOZYMIN --CCK-PZ ALUMINUM CHLORHYDROXIDE COMPLEX ACH-TYPE A-23 BENADRYL POWDER PROTAMINE HCL, RO 6-1588/1

Page 29

4Q2012EXCEL DMF# 1052 1053 1054 I 1055 1056 1057 I 1058 1059 1060 1061 1062 1063 1064 1065 1066 1067 I 1068 1069 1070 1071 1072 1073 I 1074 1075 I 1076 1077 1078 1079 1080 I 1081 1082 1083 1084 1085 1086 1087 A I I I I I I II II I III 9/6/1967 9/15/1967 9/25/1967 9/13/1967 10/4/1967 10/6/1967 10/18/1967 A I I I II II 8/15/1967 8/25/1967 8/28/1967 9/6/1967 9/7/1967 I II 6/27/1967 8/7/1967 I I I I I II 5/6/1967 7/17/1967 6/22/1967 7/19/1967 7/26/1967 8/4/1967 I I A I I I I I I II I II I II II III 5/2/1967 5/10/1967 5/2/1967 5/2/1967 5/19/1967 5/29/1967 6/6/1967 6/21/1967 6/21/1967 6/29/1967 I I 4/25/1967 4/26/1967 5/2/1967 STATUS Type SUBMIT DATE I I I 4/3/1967 4/17/1967 4/21/1967 HOLDER DOW CHEMICAL CO MICHIGAN DIV CHATTEM DRUG & CHEMICAL COMPANY FUJISAWA PHARMACEUTICAL COMPANY LTD FRANK H FLEER CORP MACLIN CO LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO ALLIED CHEM CORP MICRO CHEMS LTD KLOCKNER PENTAPLAST OF AMERICA INC ALLIED CHEM CORP SYNTEX CORP CALBIOCHEM-BEHRING CORP FERRING AB ICI PHARMA SYNTEX CHEMICALS INC ARAPAHOE CHEMS INC DIV SYNTEX LABS INC WINGENROTH LEONORA MILES INC IMPERIAL CHEMICAL INDUSTRIES PLC PURDUE FREDERICK CO EI DUPONT DE NEMOURS AND CO SUBJECT UNS-TETRAFLUOROETHANE ALUMINUM CHLORHYDROXIDE COMPLEX, TYPE A-34 SYNTHESIS OF PYRROINITRIN CHEWING GUM COMPOUND MACLIN COMPOUND VM-1921---POLYVINYL CHLORIDE ACETATE DICHLOROMETHOTREXATE CP 014 COPOLYMER HYDROCHLOROTHIAZIDE USP MIRREX MCFD RIGID VINYL SHEET.PRODS X-2002M PVC BOTTLE BLOWING RESIN FREEPORT FACILITIES DOPAMINE HCL ACTH STANDARD DRUG MIXTURE NO. 22 GENERAL MASTER FILE (THIS DFORMERLY ARAPAHOE CHEMICALS, INC) DIMETHYL SULFOXIDE JOST STERILE PACK AND PROCESS METHOXYPHENAMINE HCL COOMASSIE BLUE CLINICAL INVESTIGATORS SR-87M GENERATORS

4Q2012

AMOCO CHEMS CORP AFFILIATE AMERICAN INDOPOL POLYBUTENES OIL CO SOLVAY PHARMACEUTICALS MANUFACTURING CONTROL INFORMATION FOR--LITHIUM CARBONATE BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO AJINOMOTO CO INC ER SQUIBB AND SONS INC NORWICH PHARMACAL CO NYSCO LABS INC PHARMACEUTICAL FLAVOR CLINIC DIV OF FOOTE & JENKS BILCARE RESEARCH GMBH NYSCO LABS INC SYNTEX USA INC SYNTEX USA INC AMERICAN CYANAMID CO PURDUE FREDERICK CO RICHARDSON-MERRELL INC NEOCARZINOSTAIN AMINO ACID PRODUCTS MANUFACTURE OF HYDROXYUREA MANUFACTURING AND QUALITY CONTROL DEXTRO-AMPHETAMINE SULFATE PHARMACEUTICAL FLAVORS PVC FILM MANUFACTURED IN SCHLOSSMATENSTRASSE 2, GERMANY. PENITE TIMED RELEASE CAPSULES RESEARCH STEROIDS NORETHINDRONE ACETATE CONSUMER PRODUCTS DIVISION MANUFACTURE AND CONTROL OPERATIONS DIETHYLPROPION HCL

Page 30

4Q2012EXCEL DMF# 1088 1089 I 1090 1091 I 1092 1093 1094 1095 1096 1097 1098 1099 1100 1101 1102 1103 1104 I 1105 I 1106 1107 I 1108 I 1109 1110 1111 I 1112 1113 1114 1115 1116 1117 1118 1119 1120 1121 I 1122 I II 1/17/1968 I I I A I I I I I IV II II II II III 12/20/1967 12/20/1967 1/2/1968 12/28/1967 1/2/1968 1/18/1967 12/18/1967 1/3/1968 1/4/1968 1/5/1968 I I IV 12/18/1967 12/18/1967 12/12/1967 12/15/1967 I 12/11/1967 12/11/1967 12/8/1967 I I I I I I I I I A I I II II IV III I III II 10/24/1967 10/25/1967 10/27/1967 11/2/1967 11/8/1967 11/9/1967 11/17/1967 11/24/1967 11/27/1967 9/11/1967 11/30/1967 12/1/1967 12/6/1967 I 10/19/1967 10/23/1967 STATUS Type SUBMIT DATE I 10/17/1967 10/17/1967 HOLDER RICHARDSON-MERRELL INC SUBJECT DIETHYLPROPION HCL WITH TARTARIC ACID

4Q2012

ABBOTT LABORATORIES PHARMACEUTICAL MEPROBAMATE PRODUCTS DIV NYSCO LABS INC BUTA-PENITE TIMED RELEASE CAPSULES VICTOR M HERMELIN CO DIV K-V PHARMACAL CO CENTURY PACKAGING CORP SCHERING AG CHEMDEX INC SF DURST AND CO INC DELAWARE CITY PLASTICS CORP UNITED STATES DEPARTMENT ENERGY ER SQUIBB AND SONS INC HERCULES INC STANDARD PHARMACAL CORP PECHINEY PLASTIC PACKAGING INC RICHLYN LABORATORIES INC PHILLIPS FILMS COMPANY INC PETN 80MG SUSTAINED RELEASE CAPSULES PACKAGING FACILITIES AND CONTROLS ESTRADIOL ENANTHATE IRON HY-DEX HUMAN USE DEXAMETHASONE DIAMOND PVC-500 RESIN TIN-113/INDIUM-113M (DFORMERLY HELD BY UNION CARBIDE CORP) PLASTIBASE (SQUIBB PLASTICIZED HYDROCARBON GEL) STAYBELITE RESIN MANUFACTURING FACILITIES AND CONTROLS PACKAGING FILMS FACILITIES, PERSONNEL AND CONTROLS IN CONNECTION WITH NEW DRUGS ELASTOTHERM F. FILM

VICTOR M HERMELIN CO DIV K-V DRISTAN CAPSULES PHARMACAL CO AYERST LABORATORIES INC DIV AMERICAN CF-100 OINTMENT HOME PRODUCTS CORP CONTINENTAL CAN COMPANY 104 CLS CAN ENAMEL DISTILLATION PROD INDS DIV EASTMAN KODAK CO DAVIES ROSE HOYT PHARM DIV KENDALL CO TENNESSEE EASTMAN CO-ORIG SCHERING AG INTERNATIONAL FLAVORS AND FRAGRANCES INC VALSPAR CORP VALSPAR CORP CHATTEM DRUG & CHEMICAL COMPANY EVONIK DEGUSSA CORP UNITED STATES DEPARTMENT ENERGY UNITED STATES DEPARTMENT ENERGY UNITED STATES DEPARTMENT ENERGY U.S. DEPARTMENT OF ENERGY REYNAUD LTD ETHYL PHENYLUNDECYLATE (EASTMAN 7045) MANUFACTURING, PACKAGING AND CONTROL PROCEDURES METHYL 2-CYANOACRYLATE DROXONE FLAVORS AS MANUFACTURED IN THE EMERSON, NEW JERSEY FACILITY. MOBILE PACKAGING COATING FORMULATION S-988-025 MOBILE PACKAGING COATING FORMULATION S-7007-006 ALUMINUM CHLORHYDROXIDE COMPLEX AEROSIL CESIUM-131 (DFORMERLY HELD BY UNION CARBIDE CORP) MERCURY-197 (DFORMERLY HELD BY UNION CARBIDE CORP) MERCURY-203 (DFORMERLY HELD BY UNION CARBIDE CORP) IODINE-123 (DFORMERLY HELD BY UNION CARBIDE CORP) REYNO CLOUD

GLENBROOK LABORATORIES DIV STERLING GENERAL DESCRIPTION OF FACILITIES, MANUFACTURING AND CONTROLS DRUG INC UNITED STATES DEPARTMENT ENERGY MOLYBDENUM-99-P-2 (DFORMERLY HELD BY UNION CARBIDE CORP)

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4Q2012EXCEL DMF# 1123 1124 1125 I 1126 1127 1128 1129 I 1130 1131 1132 1133 1134 1135 1136 1137 1138 1139 1140 I 1141 1142 1143 I 1144 1145 A 1146 1147 I 1148 1149 1150 1151 I 1152 1153 1154 1155 1156 1157 1158 I I I I A I I III I I II 3/11/1968 3/11/1968 3/15/1968 3/8/1968 2/28/1968 3/21/1968 3/7/1968 I I I I 3/7/1968 3/7/1968 3/8/1968 3/8/1968 N 3/5/1968 I III 2/16/1968 2/8/1968 MONSANTO COMPANY DEWEY AND ALMY CHEM DIV WR GRACE AND CO NOT AN ASSIGNED NUMBER VICTOR M HERMELIN CO DIV K-V PHARMACAL CO UNION CARBIDE CORPORATION UNION CARBIDE CORPORATION GENERAL ELECTRIC CO VICTOR M HERMELIN CO DIV K-V PHARMACAL CO UNITED STATES DEPARTMENT ENERGY HARTE & COMPANY INC PHARMACAPS INC GENERAL ELECTRIC CO AMCOR FLEXIBLES INC STRIP-PACK CO KIMBERLY CLARK CORP I I III II I 2/9/1968 2/9/1968 2/14/1968 I I I I I I I I I I II II II II II II II 1/22/1968 1/25/1968 1/24/1968 1/24/1968 1/31/1968 1/30/1968 2/1/1968 1/30/1968 2/2/1968 2/5/1968 2/1/1968 I I I 1/15/1968 1/15/1968 1/16/1968 1/18/1968 EI DUPONT DE NEMOURS AND CO CILAG CHEMIE AG ROUSSEL CORPORATION STATUS Type SUBMIT DATE I I II II I 1/17/1968 1/17/1968 1/10/1968 HOLDER UNITED STATES DEPARTMENT ENERGY U.S. DEPARTMENT OF ENERGY HEXAGON LABORATORIES INC SUBJECT MOLYBDENUM-99-P-1 (DFORMERLY HELD BY UNION CARBIDE CORP) PHOSPHORUS-32 (DFORMERLY HELD BY UNION CARBIDE CORP) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES . IN-113M GENERATORS 3-AMINOOPROPIONITRILE FUMARATE MAHAQUALONE

4Q2012

WARNER CHILCOTT DIV WARNER LAMBERT SPECIAL MATERIALS CO HOECHST CELANESE CORP BLOOD PLASMA TUBES TYPE BLU 1 AND TF70 TROJAN POWDER CO UNITED STATES DEPARTMENT ENERGY MALLINCKRODT INC AMERICAN CYANAMID CO UNITED STATES DEPARTMENT ENERGY UNITED STATES DEPARTMENT ENERGY U.S. DEPARTMENT OF ENERGY INTERNATL CHEM & NUCLEAR PHARMS INC SCHWARTZ MANN MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC VALSPAR CORP DBI INC NEPERA INC PENTAERYTHRITOL TETRANITRATE (PETN) CHROMIUM-51 (DFORMERLY HELD BY UNION CARBIDE CORP) DIARIZOIC ACID VITAMIN B 12 WITH INTRINSIC CONCENTRATE STRONTIUM-85 (DFORMERLY HELD BY UNION CARBIDE CORP) IRON-59 (DFORMERLY HELD BY UNION CARBIDE CORP) IODINE-131 (DFORMERLY HELD BY UNION CARBIDE CORP) 5-FLUOROURACIL TRITURATED THYMIDINE IN STERILE PYROGEN-FREE SOLUTION QUALIFICATIONS OF RESEARCH PERSONNEL CONTAINER COATING, PRE-STRIPS GOLD ENAMEL (#563-803) DEXAMETHASONE ACETATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. ETHANE-1-HYDROXY-1,1-DIHOSPHONIC ACID DISODIUM SALT DAREX CAN SEALING COMPOUND

PENTRITOL (PENTAERYTHRITOL TETRABUTRATE) TEMPULES 30MG C.R.C BAKELITE BRAND VGAB-0613 NATURAL 7 VINYL SHEET BAKELITE BRAND VGAB-0607 NATURAL 7 VINYL SHEET MOLYBDENUM-99 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. MOLYBDENUM-99-P-3 (DFORMERLY HELD BY UNION CARBIDE CORP) PVC RESIN COMPOUNDS METHODS, FACILITIES AND CONTROLS MERCURY-197 METALAM AND MARAFLEX 7F-452 MANUFACTURE & CONTROL PROCEDURES FOR PACKAGING KIMFOL BRAND POLYCARBONATE FILM

Page 32

4Q2012EXCEL DMF# 1159 I 1160 1161 1162 I 1163 1164 1165 1166 1167 1168 1169 A 1170 1171 I 1172 1173 1174 1175 1176 1177 1178 1179 1180 1181 1182 1183 1184 1185 1186 1187 1188 1189 1190 1191 1192 I 1193 1194 1195 I I I III IV 5/31/1968 6/12/1968 6/17/1968 I I I I I I I