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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 202552

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NDA 202552 describes ACITRETIN, which is a drug marketed by Alembic, Barr Labs Inc, Impax Labs Inc, Mylan, 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 202552

Tradename:	ACITRETIN
Applicant:	Impax Labs Inc
Ingredient:	acitretin
Patents:	0

Pharmacology for NDA: 202552

Medical Subject Heading (MeSH) Categories for 202552

Keratolytic Agents

Suppliers and Packaging for NDA: 202552

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACITRETIN	acitretin	CAPSULE;ORAL	202552	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1750	0115-1750-08	30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1750-08)
ACITRETIN	acitretin	CAPSULE;ORAL	202552	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1751	0115-1751-08	30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1751-08)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Dec 23, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	17.5MG
Approval Date:	Dec 23, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	22.5MG
Approval Date:	Dec 23, 2015	TE:	AB	RLD:	No

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