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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 077684

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NDA 077684 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 077684

Tradename:	TRETINOIN
Applicant:	Barr Labs Inc
Ingredient:	tretinoin
Patents:	0

Medical Subject Heading (MeSH) Categories for 077684

Antineoplastic Agents
Keratolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Jun 22, 2007	TE:		RLD:	No

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