Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073516
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOPROFEN KETOPROFEN 50MG CAPSULE;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
12/22/1992 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-30 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/09/2016 SUPPL-28 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/29/2006 SUPPL-23 Labeling

Label is not available on this site.

03/08/2006 SUPPL-21 Labeling

Label is not available on this site.

10/24/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

01/14/2000 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

03/26/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/14/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/10/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/13/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/17/1998 SUPPL-9 Labeling

Label is not available on this site.

03/14/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/14/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/31/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/15/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

KETOPROFEN

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KETOPROFEN KETOPROFEN 50MG CAPSULE;ORAL Prescription No AB 074014 HERITAGE PHARMS INC
KETOPROFEN KETOPROFEN 50MG CAPSULE;ORAL Prescription No AB 073516 TEVA

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