Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072004
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 800MG 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
11/18/1987 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
05/09/2016 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

12/05/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/02/1992 SUPPL-10 Labeling

Label is not available on this site.

04/07/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/14/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/28/1989 SUPPL-7 Labeling

Label is not available on this site.

12/30/1988 SUPPL-5 Labeling

Label is not available on this site.

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

Label is not available on this site.

10/17/1988 SUPPL-3 Labeling

Label is not available on this site.

01/13/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/24/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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