Drugs@FDA document

MIFEPRISTONE REMS · ANDA 091178 ORIG-1

Drugs@FDA document · GENBIOPRO · Nov 7, 2023

Key facts

Drug name MIFEPRISTONE
Document type REMS
Application ANDA091178
Submission ORIG-1
Company GENBIOPRO
Document date Nov 7, 2023

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Drugs@FDA posts the letters, labels, reviews and other documents behind each drug application and supplement. Orca1 indexes every document's full text and flags complete response letters.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA application documents · Source date:

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