Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070099
Company: BASF
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBU 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
03/29/1985 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
02/15/1995 SUPPL-27 Labeling

Label is not available on this site.

08/11/1995 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/20/1992 SUPPL-24 Labeling

Label is not available on this site.

10/17/1991 SUPPL-23 Labeling

Label is not available on this site.

08/03/1992 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/03/1992 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/06/1991 SUPPL-20 Labeling

Label is not available on this site.

08/16/1990 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/27/1989 SUPPL-18 Labeling

Label is not available on this site.

01/10/1989 SUPPL-16 Labeling

Label is not available on this site.

10/07/1988 SUPPL-15 Labeling

Label is not available on this site.

02/08/1988 SUPPL-14 Labeling

Label is not available on this site.

08/27/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/27/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/20/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/20/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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