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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072095
Company: PERRIGO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAB-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
01/16/2008 SUPPL-54 Labeling

Label is not available on this site.
03/31/2006 SUPPL-49 Labeling

Label is not available on this site.
01/09/2004 SUPPL-35 Labeling

Label is not available on this site.
09/12/2001 SUPPL-29 Labeling

Label is not available on this site.
08/21/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.
08/21/2001 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/26/2000 SUPPL-26 Labeling

Label is not available on this site.
02/20/2004 SUPPL-25 Labeling

Label is not available on this site.
03/27/2000 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.
10/01/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
03/11/1999 SUPPL-22 Labeling

Label is not available on this site.
07/15/1996 SUPPL-20 Labeling

Label is not available on this site.
07/25/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
07/25/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
07/22/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
07/22/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
07/22/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
06/01/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
07/15/1996 SUPPL-12 Labeling

Label is not available on this site.
04/06/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
07/11/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
11/30/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
11/30/1992 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.
02/11/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
03/18/1992 SUPPL-5 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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