Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 211645
Company: TARO

Products on ANDA 211645

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRETINOIN	TRETINOIN	0.1%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211645

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/22/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211645

TRETINOIN

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RETIN-A	TRETINOIN	0.1%	CREAM;TOPICAL	Prescription	Yes	AB	017340	VALEANT PHARMS NORTH
TRETINOIN	TRETINOIN	0.1%	CREAM;TOPICAL	Prescription	No	AB	075213	PADAGIS US
TRETINOIN	TRETINOIN	0.1%	CREAM;TOPICAL	Prescription	No	AB	211645	TARO