Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213508
Company: ALEMBIC

Products on ANDA 213508

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADAPALENE	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213508

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/18/2020	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
03/02/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213508

ADAPALENE

GEL;TOPICAL; 0.3%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ADAPALENE	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	No	AB	201000	ACTAVIS MID ATLANTIC
ADAPALENE	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	No	AB	213508	ALEMBIC
ADAPALENE	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	No	AB	200298	ENCUBE ETHICALS
ADAPALENE	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	No	AB	208322	SUN PHARMA CANADA
DIFFERIN	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	Yes	AB	021753	GALDERMA LABS LP