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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074514
Company: ACTAVIS ELIZABETH

Products on ANDA 074514

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074514

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
04/28/2021	SUPPL-44	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/31/2021	SUPPL-41	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 074514

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	216548	RUBICON
DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	090066	UNIQUE

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	216548	RUBICON
DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	077863	UNIQUE

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