Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071231
Company: VINTAGE PHARMS
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
10/22/1986 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
05/09/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

12/05/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/02/1992 SUPPL-12 Labeling

Label is not available on this site.

12/14/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/29/1990 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/28/1989 SUPPL-9 Labeling

Label is not available on this site.

12/30/1988 SUPPL-7 Labeling

Label is not available on this site.

01/13/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/11/1988 SUPPL-5 Labeling

Label is not available on this site.

01/13/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/27/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/27/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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