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Serving leading biopharmaceutical companies globally:

Farmers Insurance
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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202148

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NDA 202148 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 202148
Applicant:Mylan Pharms Inc
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202148
Medical Subject Heading (MeSH) Categories for 202148
Suppliers and Packaging for NDA: 202148
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACITRETIN acitretin CAPSULE;ORAL 202148 ANDA Mylan Pharmaceuticals Inc. 0378-7020 N 0378-7020-93
ACITRETIN acitretin CAPSULE;ORAL 202148 ANDA Mylan Pharmaceuticals Inc. 0378-7023 N 0378-7023-93

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Sep 10, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Sep 10, 2015TE:ABRLD:No

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