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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209196Orig1s000 PRODUCT QUALITY REVIEW(S)

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Page 1: 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

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209196Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 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
Page 3: 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
Page 4: 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
Page 5: 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
Page 6: 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
Page 7: 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
Page 8: 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
Page 9: 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
Page 10: 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
Page 11: 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
Page 12: 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
Page 13: 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

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