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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Fish and Richardson

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091455

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NDA 091455 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 091455
Applicant:Barr Labs Inc
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091455
Medical Subject Heading (MeSH) Categories for 091455
Suppliers and Packaging for NDA: 091455
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACITRETIN acitretin CAPSULE;ORAL 091455 ANDA Teva Pharmaceuticals USA, Inc. 0093-1135 N 0093-1135-56
ACITRETIN acitretin CAPSULE;ORAL 091455 ANDA Teva Pharmaceuticals USA, Inc. 0093-1136 N 0093-1136-56

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Apr 4, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Apr 4, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health

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