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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 201687

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NDA 201687 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 201687

Tradename:	TRETINOIN
Applicant:	Ph Health
Ingredient:	tretinoin
Patents:	0

Pharmacology for NDA: 201687

Medical Subject Heading (MeSH) Categories for 201687

Antineoplastic Agents
Keratolytic Agents

Suppliers and Packaging for NDA: 201687

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRETINOIN	tretinoin	CAPSULE;ORAL	201687	ANDA	Major Pharmaceuticals	0904-6867	0904-6867-04	30 BLISTER PACK in 1 CARTON (0904-6867-04) / 1 CAPSULE in 1 BLISTER PACK
TRETINOIN	tretinoin	CAPSULE;ORAL	201687	ANDA	Endo USA, Inc.	10370-268	10370-268-01	100 CAPSULE in 1 BOTTLE (10370-268-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Oct 24, 2012	TE:	AB	RLD:	No

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