Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071735
Company: CONTRACT PHARMACAL
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
09/10/1987 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
03/22/2006 SUPPL-19 Labeling

Label is not available on this site.

12/01/1999 SUPPL-17 Labeling

Label is not available on this site.

07/23/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/15/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/24/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/24/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/24/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/24/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/23/1990 SUPPL-8 Bioequivalence

Label is not available on this site.

08/27/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/27/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/12/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/12/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/12/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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