Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070745
Company: BASF
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBU 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
07/23/1986 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
02/27/1995 SUPPL-15 Labeling

Label is not available on this site.

02/15/1995 SUPPL-14 Labeling

Label is not available on this site.

08/11/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/17/1991 SUPPL-9 Labeling

Label is not available on this site.

08/06/1991 SUPPL-8 Labeling

Label is not available on this site.

10/27/1989 SUPPL-7 Labeling

Label is not available on this site.

06/08/1989 SUPPL-6 Labeling

Label is not available on this site.

01/10/1989 SUPPL-5 Labeling

Label is not available on this site.

01/27/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/07/1988 SUPPL-3 Labeling

Label is not available on this site.

03/01/1988 SUPPL-2 Labeling

Label is not available on this site.

09/03/1986 SUPPL-1 Labeling

Label is not available on this site.

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