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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 202552


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NDA 202552 describes ACITRETIN, which is a drug marketed by Barr Labs Inc, Impax Labs Inc, Mylan, Sigmapharm Labs Llc, and Teva Pharms Usa, and is included in six NDAs. It is available from six 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. Six 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 202552
Medical Subject Heading (MeSH) Categories for 202552
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:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Dec 23, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength17.5MG
Approval Date:Dec 23, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength22.5MG
Approval Date:Dec 23, 2015TE:ABRLD:No

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