Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219565
Company: UNIQUE

Products on ANDA 219565

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADAPALENE	ADAPALENE	0.1%	GEL;TOPICAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219565

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

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

ADAPALENE

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

GEL;TOPICAL; 0.1%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ADAPALENE	ADAPALENE	0.1%	GEL;TOPICAL	Over-the-counter	No	091314	GLENMARK PHARMS
ADAPALENE	ADAPALENE	0.1%	GEL;TOPICAL	Over-the-counter	No	091314	GLENMARK PHARMS
ADAPALENE	ADAPALENE	0.1%	GEL;TOPICAL	Over-the-counter	No	090962	P AND L
ADAPALENE	ADAPALENE	0.1%	GEL;TOPICAL	Over-the-counter	No	215940	SUN PHARMA CANADA
ADAPALENE	ADAPALENE	0.1%	GEL;TOPICAL	Over-the-counter	No	219565	UNIQUE
DIFFERIN	ADAPALENE	0.1%	GEL;TOPICAL	Over-the-counter	Yes	020380	GALDERMA LABS LP