Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072902
Company: SUN PHARM INDUSTRIES
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
12/21/1990 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-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/16/2007 SUPPL-17 Labeling

Label is not available on this site.

05/16/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

12/05/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/06/1993 SUPPL-2 Labeling

Label is not available on this site.

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