Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072267
Company: XSPIRE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENOPROFEN CALCIUM FENOPROFEN CALCIUM EQ 600MG BASE TABLET;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/08/1988 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-23 Labeling-Medication Guide

Label is not available on this site.

04/24/2015 SUPPL-22 Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

12/20/2007 SUPPL-19 Labeling

Label is not available on this site.

05/16/2006 SUPPL-16 Labeling

Label is not available on this site.

03/13/2006 SUPPL-15 Labeling

Label is not available on this site.

02/05/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/26/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/04/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/09/1991 SUPPL-9 Labeling

Label is not available on this site.

10/31/1991 SUPPL-8 Labeling

Label is not available on this site.

10/31/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/31/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/11/1988 SUPPL-3 Labeling

Label is not available on this site.

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