Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218245
Company: AUROBINDO PHARMA LTD

Products on ANDA 218245

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRETINOIN	TRETINOIN	0.025%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218245

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218245

TRETINOIN

GEL;TOPICAL; 0.025%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RETIN-A	TRETINOIN	0.025%	GEL;TOPICAL	Prescription	Yes	AB	017579	VALEANT INTL
TRETINOIN	TRETINOIN	0.025%	GEL;TOPICAL	Prescription	No	AB	218245	AUROBINDO PHARMA LTD
TRETINOIN	TRETINOIN	0.025%	GEL;TOPICAL	Prescription	No	AB	217587	ENCUBE
TRETINOIN	TRETINOIN	0.025%	GEL;TOPICAL	Prescription	No	AB	075529	PADAGIS US