Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018197
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
RUFEN 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
05/21/1981 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
03/06/1995 SUPPL-30 Labeling

Label is not available on this site.

01/05/1995 SUPPL-29 Labeling

Label is not available on this site.

10/09/1991 SUPPL-27 Labeling

Label is not available on this site.

10/25/1989 SUPPL-26 Labeling

Label is not available on this site.

01/19/1989 SUPPL-24 Labeling

Label is not available on this site.

10/28/1988 SUPPL-23 Labeling

Label is not available on this site.

01/17/1989 SUPPL-22 Labeling

Label is not available on this site.

07/01/1986 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

01/17/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/01/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

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