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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217832
Company: ENCUBE

Products on ANDA 217832

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRETINOIN	TRETINOIN	0.05%	CREAM;TOPICAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217832

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/25/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217832

TRETINOIN

CREAM;TOPICAL; 0.05%
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RETIN-A	TRETINOIN	0.05%	CREAM;TOPICAL	Prescription	Yes	AB1	017522	VALEANT BERMUDA
TRETINOIN	TRETINOIN	0.05%	CREAM;TOPICAL	Prescription	No	AB1	217832	ENCUBE
TRETINOIN	TRETINOIN	0.05%	CREAM;TOPICAL	Prescription	No	AB1	075265	PADAGIS US
TRETINOIN	TRETINOIN	0.05%	CREAM;TOPICAL	Prescription	No	AB1	211644	SUN PHARMA CANADA

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