209196Orig1s000 life is 36 and the in-use shelf life is 28 days at (b) 300C after initial ......
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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209196Orig1s000 PRODUCT QUALITY REVIEW(S)
209196Orig1s000 life is 36 and the in-use shelf life is 28 days at (b) 300C after initial ... product has the same composition and strength as the referenced approved thug. Sanofi
