Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217833
Company: ENCUBE

Products on ANDA 217833

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 217833

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/10/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217833

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	217804	ALEMBIC
TRETINOIN	TRETINOIN	0.1%	CREAM;TOPICAL	Prescription	No	AB	217833	ENCUBE
TRETINOIN	TRETINOIN	0.1%	CREAM;TOPICAL	Prescription	No	AB	075213	PADAGIS US
TRETINOIN	TRETINOIN	0.1%	CREAM;TOPICAL	Prescription	No	AB	211645	SUN PHARMA CANADA
TRETINOIN	TRETINOIN	0.1%	CREAM;TOPICAL	Prescription	No	AB	218561	ZYDUS LIFESCIENCES