Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074411
Company: IVAX SUB TEVA PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLURBIPROFEN FLURBIPROFEN 50MG TABLET;ORAL Discontinued None No No
FLURBIPROFEN FLURBIPROFEN 100MG 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
05/31/1995 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
07/29/2002 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.
03/12/2002 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.
03/12/2002 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/20/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
12/20/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
12/20/2000 SUPPL-6 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
12/20/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.
01/28/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.
11/23/1999 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.
12/09/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
05/30/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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