Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091178
Company: GENBIOPRO

• REMS

Products on ANDA 091178

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIFEPRISTONE	MIFEPRISTONE	200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091178

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/11/2019	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/091178Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/23/2023	SUPPL-6	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/091178Orig1s006ltr.pdf
01/03/2023	SUPPL-4	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/091178Orig1s004ltr.pdf
05/14/2021	SUPPL-3	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 091178

MIFEPRISTONE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIFEPREX	MIFEPRISTONE	200MG	TABLET;ORAL	Prescription	Yes	AB	020687	DANCO LABS LLC
MIFEPRISTONE	MIFEPRISTONE	200MG	TABLET;ORAL	Prescription	No	AB	091178	GENBIOPRO