Last Updated: October 20, 2026

Details for New Drug Application (NDA): 207955

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NDA 207955 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 207955

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

Pharmacology for NDA: 207955

Medical Subject Heading (MeSH) Categories for 207955

Antineoplastic Agents
Keratolytic Agents

Suppliers and Packaging for NDA: 207955

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRETINOIN	tretinoin	GEL;TOPICAL	207955	ANDA	Mylan Pharmaceuticals Inc.	0378-8090	0378-8090-45	1 TUBE in 1 CARTON (0378-8090-45) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.05%
Approval Date:	Aug 13, 2015	TE:	AB	RLD:	No

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