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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091178
Company: GENBIOPRO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIFEPRISTONE MIFEPRISTONE 200MG TABLET;ORAL Prescription AB No No
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
05/14/2021 SUPPL-3 REMS - MODIFIED - D-N-A

Label is not available on this site.

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
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