Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072098
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 200MG 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
12/08/1987 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
09/12/2001 SUPPL-32 Labeling

Label is not available on this site.

08/21/2001 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2001 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/26/2000 SUPPL-29 Labeling

Label is not available on this site.

03/27/2000 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1999 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/1999 SUPPL-25 Labeling

Label is not available on this site.

08/16/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/25/1997 SUPPL-21 Labeling

Label is not available on this site.

07/25/1997 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/25/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/22/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/22/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/25/1996 SUPPL-14 Labeling

Label is not available on this site.

04/06/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/13/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/11/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/06/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-9 Labeling

Label is not available on this site.

01/26/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/30/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/30/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/11/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/30/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/28/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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