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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125327Orig1s000 MEDICAL REVIEW(S)

CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... leucovorin rescue until the methotrexate level is less than 0.05 to 0.1 umol/L. ... Revised SAP submitted

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Page 1: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... leucovorin rescue until the methotrexate level is less than 0.05 to 0.1 umol/L. ... Revised SAP submitted

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

125327Orig1s000

MEDICAL REVIEW(S)

Page 2: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... leucovorin rescue until the methotrexate level is less than 0.05 to 0.1 umol/L. ... Revised SAP submitted
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Page 5: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... leucovorin rescue until the methotrexate level is less than 0.05 to 0.1 umol/L. ... Revised SAP submitted
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