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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 077684

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NDA 077684 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 077684

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

Pharmacology for NDA: 077684

Medical Subject Heading (MeSH) Categories for 077684

Antineoplastic Agents
Keratolytic Agents

Suppliers and Packaging for NDA: 077684

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRETINOIN	tretinoin	CAPSULE;ORAL	077684	ANDA	Teva Pharmaceuticals USA, Inc.	0555-0808	0555-0808-02	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0555-0808-02)

Profile for product number 001

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

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