Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073515
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOPROFEN KETOPROFEN 25MG 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
12/22/1992 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
03/26/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/14/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

05/13/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/17/1998 SUPPL-8 Labeling

Label is not available on this site.

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

Label is not available on this site.

03/14/1997 SUPPL-6 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.

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