BCS waiver [Dissolution / BCS / IVIVC]

posted by meghalvakil20 – 2016-04-28 01:04 (2891 d 23:52 ago) – Posting: # 16253
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Is there a way we can find out if the generic drug application approved by FDA had submitted BCS waiver for any of the strengths and found to be bioequivalent for example Capecitatine. there are 3 generics approved by US FDA and 2 approval letters posted but how do we know if it was submitted with a BCS waiver and was approved.


Edit: Please follow the Forum’s Policy. [Helmut]

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