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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 218245

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NDA 218245 describes TRETINOIN, which is a drug marketed by Barr Labs Inc, Glenmark Pharms Ltd, Ph Health, Alembic, Allergan, Encube, Padagis Us, Sun Pharma Canada, Zo Skin Health, Zydus Lifesciences, Aurobindo Pharma Ltd, Mylan, Rising, Teva Pharms, and Wockhardt, and is included in twenty-eight NDAs. It is available from twenty-one suppliers. Additional details are available on the TRETINOIN profile page.

The generic ingredient in TRETINOIN is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

Summary for 218245

Tradename:	TRETINOIN
Applicant:	Aurobindo Pharma Ltd
Ingredient:	tretinoin
Patents:	0

Pharmacology for NDA: 218245

Medical Subject Heading (MeSH) Categories for 218245

Antineoplastic Agents
Keratolytic Agents

Suppliers and Packaging for NDA: 218245

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRETINOIN	tretinoin	GEL;TOPICAL	218245	ANDA	Aurobindo Pharma Limited	59651-713	59651-713-14	1 TUBE in 1 CARTON (59651-713-14) / 15 g in 1 TUBE
TRETINOIN	tretinoin	GEL;TOPICAL	218245	ANDA	Aurobindo Pharma Limited	59651-713	59651-713-46	1 TUBE in 1 CARTON (59651-713-46) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.025%
Approval Date:	Feb 27, 2025	TE:	AB	RLD:	No

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