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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 202897

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NDA 202897 describes ACITRETIN, which is a drug marketed by Alembic, Barr Labs Inc, Impax Labs Inc, Mylan, Norvium Bioscience, Sigmapharm Labs Llc, and Teva Pharms Usa, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the ACITRETIN profile page.

The generic ingredient in ACITRETIN is acitretin. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acitretin profile page.

Summary for 202897

Tradename:	ACITRETIN
Applicant:	Teva Pharms Usa
Ingredient:	acitretin
Patents:	0

Pharmacology for NDA: 202897

Medical Subject Heading (MeSH) Categories for 202897

Keratolytic Agents

Suppliers and Packaging for NDA: 202897

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACITRETIN	acitretin	CAPSULE;ORAL	202897	ANDA	Teva Pharmaceuticals USA, Inc.	0093-1138	0093-1138-56	30 CAPSULE in 1 BOTTLE (0093-1138-56)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	17.5MG
Approval Date:	Apr 4, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	22.5MG
Approval Date:	Apr 4, 2013	TE:	AB	RLD:	No

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