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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Cantor Fitzgerald
Daiichi Sankyo

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204633

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NDA 204633 describes ACITRETIN, which is a drug marketed by Barr Labs Inc, Impax Labs Inc, Mylan Pharms Inc, 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. Eight suppliers are listed for this compound. Additional details are available on the acitretin profile page.

Summary for 204633

Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204633


Medical Subject Heading (MeSH) Categories for 204633

Suppliers and Packaging for NDA: 204633

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACITRETIN acitretin CAPSULE;ORAL 204633 ANDA AvKARE, Inc. 42291-086 42291-086-30 30 CAPSULE in 1 BOTTLE (42291-086-30)
ACITRETIN acitretin CAPSULE;ORAL 204633 ANDA AvKARE, Inc. 42291-087 42291-087-30 30 CAPSULE in 1 BOTTLE (42291-087-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:May 22, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength17.5MG
Approval Date:May 22, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength22.5MG
Approval Date:May 22, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Cantor Fitzgerald

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