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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215713
Company: TARO

Products on ANDA 215713

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215713

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/05/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215713

TRETINOIN

CREAM;TOPICAL; 0.025%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AVITA	TRETINOIN	0.025%	CREAM;TOPICAL	Prescription	No	AB	020404	MYLAN PHARMS INC
RETIN-A	TRETINOIN	0.025%	CREAM;TOPICAL	Prescription	Yes	AB	019049	BAUSCH
TRETINOIN	TRETINOIN	0.025%	CREAM;TOPICAL	Prescription	No	AB	075264	PADAGIS US
TRETINOIN	TRETINOIN	0.025%	CREAM;TOPICAL	Prescription	No	AB	215713	TARO

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