Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074431
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLURBIPROFEN FLURBIPROFEN 100MG TABLET;ORAL Prescription AB 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
11/29/2010 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

04/25/2006 SUPPL-15 Labeling

Label is not available on this site.

03/13/2006 SUPPL-14 Labeling

Label is not available on this site.

08/30/2001 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

08/27/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/07/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/07/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/07/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/21/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/22/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

FLURBIPROFEN

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLURBIPROFEN FLURBIPROFEN 100MG TABLET;ORAL Prescription No AB 074358 MYLAN
FLURBIPROFEN FLURBIPROFEN 100MG TABLET;ORAL Prescription No AB 074431 TEVA

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