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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076201
Company: DEXCEL LTD

Products on ANDA 076201

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076201

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/06/2002	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
11/21/2024	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
03/01/2024	SUPPL-29	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/14/2014	SUPPL-10	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
07/06/2010	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/31/2009	SUPPL-8	Labeling		Label is not available on this site.
11/29/2006	SUPPL-6	Labeling		Label is not available on this site.
03/13/2006	SUPPL-5	Labeling		Label is not available on this site.
10/23/2003	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076201

DICLOFENAC SODIUM

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076201	DEXCEL LTD
DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216275	INGENUS PHARMS LLC
DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075492	VPNA

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