Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072326
Company: DAVA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENOPROFEN CALCIUM FENOPROFEN CALCIUM EQ 600MG BASE TABLET;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
04/20/1988 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
11/04/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1999 SUPPL-9 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/01/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/06/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/15/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/31/1989 SUPPL-5 Labeling

Label is not available on this site.

12/15/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/15/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/20/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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