Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070083
Company: BASF
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBU 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
02/22/1985 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-20 Labeling

Label is not available on this site.

08/11/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/03/1993 SUPPL-16 Labeling

Label is not available on this site.

03/11/1992 SUPPL-15 Labeling

Label is not available on this site.

10/24/1991 SUPPL-14 Labeling

Label is not available on this site.

08/06/1991 SUPPL-13 Labeling

Label is not available on this site.

09/06/1989 SUPPL-12 Labeling

Label is not available on this site.

02/14/1989 SUPPL-10 Labeling

Label is not available on this site.

02/14/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/01/1988 SUPPL-8 Labeling

Label is not available on this site.

05/23/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/16/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/16/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/16/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/16/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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