Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208077
Company: AMNEAL PHARMS

Products on ANDA 208077

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL;TOPICAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208077

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/18/2016	ORIG-1	Approval		STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208077Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/13/2020	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

DICLOFENAC SODIUM

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

GEL;TOPICAL; 1%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL;TOPICAL	Over-the-counter	No	208077	AMNEAL PHARMS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL;TOPICAL	Over-the-counter	No	204306	AUROLIFE PHARMA LLC
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL;TOPICAL	Over-the-counter	No	210986	ENCUBE
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL;TOPICAL	Over-the-counter	No	211253	PERRIGO PHARMA INTL
VOLTAREN ARTHRITIS PAIN	DICLOFENAC SODIUM	1%	GEL;TOPICAL	Over-the-counter	Yes	022122	HALEON US HOLDINGS