Last Updated: October 8, 2026

Details for New Drug Application (NDA): 203707

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NDA 203707 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 is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the acitretin profile page.

Summary for 203707

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

Medical Subject Heading (MeSH) Categories for 203707

Keratolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	17.5MG
Approval Date:	Sep 10, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	22.5MG
Approval Date:	Sep 10, 2015	TE:		RLD:	No

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