Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072396
Company: AUROLIFE PHARMA LLC
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
10/17/1988 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-8 Labeling-Package Insert

Label is not available on this site.

04/18/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/30/1991 SUPPL-6 Labeling

Label is not available on this site.

02/27/1989 SUPPL-5 Bioequivalence

Label is not available on this site.

02/27/1989 SUPPL-3 Bioequivalence

Label is not available on this site.

03/31/1989 SUPPL-2 Labeling

Label is not available on this site.

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