Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074035
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOPROFEN KETOPROFEN 50MG CAPSULE;ORAL Discontinued None No No
KETOPROFEN KETOPROFEN 75MG CAPSULE;ORAL Discontinued None 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
12/31/1996 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2021 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-13 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/08/2008 SUPPL-9 Labeling

Label is not available on this site.

07/03/2006 SUPPL-6 Labeling

Label is not available on this site.

06/26/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/1998 SUPPL-3 Labeling

Label is not available on this site.

02/05/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/22/1997 SUPPL-1 Labeling

Label is not available on this site.

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