Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071462
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 200MG 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
10/02/1986 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
12/01/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/18/1993 SUPPL-20 Labeling

Label is not available on this site.

05/18/1993 SUPPL-19 Labeling

Label is not available on this site.

04/03/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/12/1995 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/12/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/06/1991 SUPPL-13 Labeling

Label is not available on this site.

01/05/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/06/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/25/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/27/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/09/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/09/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/09/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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