Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073673
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIFLUNISAL DIFLUNISAL 500MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/31/1992 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
05/09/2016 SUPPL-28 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/14/2006 SUPPL-26 Labeling

Label is not available on this site.

04/25/2006 SUPPL-25 Labeling

Label is not available on this site.

03/08/2006 SUPPL-24 Labeling

Label is not available on this site.

03/08/2002 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/08/2001 SUPPL-21 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/08/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1999 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/1999 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

02/12/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/12/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-10 Labeling

Label is not available on this site.

06/16/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/31/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/24/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-5 Labeling

Label is not available on this site.

08/23/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/20/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-2 Labeling

Label is not available on this site.

08/18/1992 SUPPL-1 Labeling

Label is not available on this site.

DIFLUNISAL

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIFLUNISAL DIFLUNISAL 500MG TABLET;ORAL Prescription No AB 202845 HERITAGE PHARMA
DIFLUNISAL DIFLUNISAL 500MG TABLET;ORAL Prescription No AB 073673 TEVA
DIFLUNISAL DIFLUNISAL 500MG TABLET;ORAL Prescription No AB 203547 ZYDUS PHARMS

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