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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 217774

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NDA 217774 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 217774

Tradename:	ACITRETIN
Applicant:	Alembic
Ingredient:	acitretin
Patents:	0

Pharmacology for NDA: 217774

Medical Subject Heading (MeSH) Categories for 217774

Keratolytic Agents

Suppliers and Packaging for NDA: 217774

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACITRETIN	acitretin	CAPSULE;ORAL	217774	ANDA	Alembic Pharmaceuticals Limited	46708-741	46708-741-30	30 CAPSULE in 1 BOTTLE (46708-741-30)
ACITRETIN	acitretin	CAPSULE;ORAL	217774	ANDA	Alembic Pharmaceuticals Limited	46708-742	46708-742-30	30 CAPSULE in 1 BOTTLE (46708-742-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Aug 5, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	17.5MG
Approval Date:	Aug 5, 2024	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Aug 5, 2024	TE:	AB	RLD:	No

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