Last Updated: September 28, 2026

Details for New Drug Application (NDA): 214590

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NDA 214590 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, Amneal, Aurobindo Pharma Ltd, Mylan, Rising, Teva Pharms, and Wockhardt, and is included in thirty-two NDAs. It is available from twenty-two suppliers. Additional details are available on the TRETINOIN profile page.

The generic ingredient in TRETINOIN is tretinoin. There is one drug master file entry for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

Summary for 214590

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

Pharmacology for NDA: 214590

Medical Subject Heading (MeSH) Categories for 214590

Antineoplastic Agents
Keratolytic Agents

Suppliers and Packaging for NDA: 214590

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRETINOIN	tretinoin	CREAM;TOPICAL	214590	ANDA	Alembic Pharmaceuticals Limited	46708-808	46708-808-00	1 TUBE in 1 CARTON (46708-808-00) / 45 g in 1 TUBE
TRETINOIN	tretinoin	CREAM;TOPICAL	214590	ANDA	Alembic Pharmaceuticals Limited	46708-808	46708-808-20	1 TUBE in 1 CARTON (46708-808-20) / 20 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.05%
Approval Date:	Jun 11, 2026	TE:	AB1	RLD:	No

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