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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070080
Company: SUN PHARM INDUSTRIES

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 600MG 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
07/24/1985 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
11/21/2024 SUPPL-41 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
04/30/2021 SUPPL-40 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
07/22/2019 SUPPL-39 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
05/09/2016 SUPPL-38 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/01/1998 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.
12/23/1994 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.
10/11/1994 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.
04/03/1992 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
04/03/1992 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
08/12/1991 SUPPL-31 Labeling

Label is not available on this site.
06/07/1990 SUPPL-30 Bioequivalence

Label is not available on this site.
01/10/1995 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
09/13/1989 SUPPL-27 Labeling

Label is not available on this site.
05/17/1989 SUPPL-26 Labeling

Label is not available on this site.
02/02/1989 SUPPL-25 Labeling

Label is not available on this site.
12/16/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
09/20/1988 SUPPL-23 Labeling

Label is not available on this site.
03/03/1988 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
03/03/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
03/31/1987 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
12/06/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
12/07/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
10/25/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
12/06/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
09/16/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
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