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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 076498

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NDA 076498 describes TRETINOIN, which is a drug marketed by Barr Labs Inc, Endo Operations, Glenmark Pharms Ltd, Alembic, Allergan, Padagis Us, Taro, Zo Skin Health, Zydus Lifesciences, Mylan, Norvium Bioscience, Teva Pharms, Wockhardt, and Encube, and is included in twenty-two NDAs. It is available from eighteen 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-six suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

Summary for 076498

Tradename:	TRETINOIN
Applicant:	Zo Skin Health
Ingredient:	tretinoin
Patents:	0

Medical Subject Heading (MeSH) Categories for 076498

Antineoplastic Agents
Keratolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	0.05%
Approval Date:	Sep 15, 2005	TE:		RLD:	No

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