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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 218399

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NDA 218399 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 218399

Tradename:	TRETINOIN
Applicant:	Alembic
Ingredient:	tretinoin
Patents:	0

Pharmacology for NDA: 218399

Medical Subject Heading (MeSH) Categories for 218399

Antineoplastic Agents
Keratolytic Agents

Suppliers and Packaging for NDA: 218399

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRETINOIN	tretinoin	CREAM;TOPICAL	218399	ANDA	Alembic Pharmaceuticals Limited	46708-809	46708-809-20	1 TUBE in 1 CARTON (46708-809-20) / 20 g in 1 TUBE
TRETINOIN	tretinoin	CREAM;TOPICAL	218399	ANDA	Alembic Pharmaceuticals Limited	46708-809	46708-809-45	1 TUBE in 1 CARTON (46708-809-45) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.025%
Approval Date:	Aug 14, 2025	TE:	AB	RLD:	No

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