Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076095
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MISOPROSTOL MISOPROSTOL 0.1MG TABLET;ORAL Prescription AB No No
MISOPROSTOL MISOPROSTOL 0.2MG 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
07/10/2002 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76095ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076095.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/27/2010 SUPPL-12 Labeling-Medication Guide

Label is not available on this site.

12/27/2007 SUPPL-4 Labeling

Label is not available on this site.

11/20/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

11/20/2002 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

MISOPROSTOL

TABLET;ORAL; 0.1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYTOTEC MISOPROSTOL 0.1MG TABLET;ORAL Prescription Yes AB 019268 GD SEARLE LLC
MISOPROSTOL MISOPROSTOL 0.1MG TABLET;ORAL Prescription No AB 076095 ANI PHARMS INC
MISOPROSTOL MISOPROSTOL 0.1MG TABLET;ORAL Prescription No AB 091667 NOVEL LABS INC
MISOPROSTOL MISOPROSTOL 0.1MG TABLET;ORAL Prescription No AB 210201 ZYDUS PHARMS

TABLET;ORAL; 0.2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYTOTEC MISOPROSTOL 0.2MG TABLET;ORAL Prescription Yes AB 019268 GD SEARLE LLC
MISOPROSTOL MISOPROSTOL 0.2MG TABLET;ORAL Prescription No AB 076095 ANI PHARMS INC
MISOPROSTOL MISOPROSTOL 0.2MG TABLET;ORAL Prescription No AB 091667 NOVEL LABS INC
MISOPROSTOL MISOPROSTOL 0.2MG TABLET;ORAL Prescription No AB 210201 ZYDUS PHARMS

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