Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071265
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
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
10/15/1986 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
03/21/2019 SUPPL-49 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

03/21/2019 SUPPL-48 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

03/21/2019 SUPPL-46 Labeling-Package Insert

Label is not available on this site.

03/22/2006 SUPPL-27 Labeling

Label is not available on this site.

09/29/2004 SUPPL-25 Labeling

Label is not available on this site.

12/01/1999 SUPPL-23 Labeling

Label is not available on this site.

07/23/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/24/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/28/1994 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/24/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/23/1990 SUPPL-17 Bioequivalence

Label is not available on this site.

08/27/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/27/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/18/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/18/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/18/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/02/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/06/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/21/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/21/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/21/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/06/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/14/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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