Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071146
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 600MG 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
09/23/1986 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
05/05/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/16/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/16/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/12/1991 SUPPL-16 Labeling

Label is not available on this site.

12/07/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/07/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/01/1989 SUPPL-13 Labeling

Label is not available on this site.

02/01/1989 SUPPL-12 Labeling

Label is not available on this site.

12/07/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/11/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/30/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/30/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/30/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/06/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/06/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/26/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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