Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070079
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 400MG 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
07/22/2019 SUPPL-37 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-36 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

12/01/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/11/1991 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/11/1991 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/12/1991 SUPPL-27 Labeling

Label is not available on this site.

09/13/1989 SUPPL-26 Labeling

Label is not available on this site.

05/17/1989 SUPPL-25 Labeling

Label is not available on this site.

02/02/1989 SUPPL-24 Labeling

Label is not available on this site.

12/16/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/20/1988 SUPPL-22 Labeling

Label is not available on this site.

03/04/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/04/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/27/1987 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/20/1991 SUPPL-12 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.

12/06/1985 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.

09/16/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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