Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215609
Company: ENCUBE

Products on ANDA 215609

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRETINOIN MICROSPHERE	TRETINOIN	0.08%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215609

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/22/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215609Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 215609

TRETINOIN MICROSPHERE

GEL;TOPICAL; 0.08%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RETIN-A-MICRO	TRETINOIN	0.08%	GEL;TOPICAL	Prescription	Yes	AB	020475	BAUSCH
TRETINOIN MICROSPHERE	TRETINOIN	0.08%	GEL;TOPICAL	Prescription	No	AB	215609	ENCUBE