Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211253
Company: PERRIGO PHARMA INTL

Products on ANDA 211253

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 211253

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/16/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/28/2022	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/23/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
10/23/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/01/2020	SUPPL-5	Labeling-Package Insert, Labeling-Container/Carton Labels		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