Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074514
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLOFENAC SODIUM DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE;ORAL Prescription AB No No
DICLOFENAC SODIUM DICLOFENAC SODIUM 75MG TABLET, DELAYED RELEASE;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
03/26/1996 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-37 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/07/2014 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

05/11/2009 SUPPL-25 Labeling

Label is not available on this site.

05/08/2008 SUPPL-23 Labeling

Label is not available on this site.

07/28/2006 SUPPL-16 Labeling

Label is not available on this site.

07/01/2004 SUPPL-11 Labeling

Label is not available on this site.

02/20/2004 SUPPL-9 Labeling

Label is not available on this site.

02/21/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DICLOFENAC SODIUM

TABLET, DELAYED RELEASE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLOFENAC SODIUM DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 074514 ACTAVIS ELIZABETH
DICLOFENAC SODIUM DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075185 CARLSBAD
DICLOFENAC SODIUM DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 074376 CASI PHARMS INC
DICLOFENAC SODIUM DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075281 MYLAN PHARMS INC
DICLOFENAC SODIUM DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 090066 UNIQUE PHARM LABS

TABLET, DELAYED RELEASE;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLOFENAC SODIUM DICLOFENAC SODIUM 75MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 074514 ACTAVIS ELIZABETH
DICLOFENAC SODIUM DICLOFENAC SODIUM 75MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075185 CARLSBAD
DICLOFENAC SODIUM DICLOFENAC SODIUM 75MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 074394 CASI PHARMS INC
DICLOFENAC SODIUM DICLOFENAC SODIUM 75MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075281 MYLAN PHARMS INC
DICLOFENAC SODIUM DICLOFENAC SODIUM 75MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 077863 UNIQUE PHARM LABS

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