Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072274
Company: ANI 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
05/02/1988 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
05/09/2016 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

02/18/2016 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/08/2002 SUPPL-14 Labeling

Label is not available on this site.

02/26/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/18/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/13/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/22/1991 SUPPL-8 Labeling

Label is not available on this site.

07/29/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/04/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/04/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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