Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072097
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAP-PROFEN 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-25 Labeling

Label is not available on this site.

08/21/2001 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2001 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/26/2000 SUPPL-22 Labeling

Label is not available on this site.

02/20/2004 SUPPL-21 Labeling

Label is not available on this site.

03/27/2000 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1999 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/1999 SUPPL-18 Labeling

Label is not available on this site.

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

Label is not available on this site.

07/25/1997 SUPPL-15 Labeling

Label is not available on this site.

07/25/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/25/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/22/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/22/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/22/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/25/1996 SUPPL-8 Labeling

Label is not available on this site.

04/06/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/11/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/30/1992 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.

02/11/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/30/1992 SUPPL-2 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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