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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Baxter
Queensland Health
Teva
Chinese Patent Office
Merck
Harvard Business School
Cipla
Fish and Richardson

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203898

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NDA 203898 describes TEMOZOLOMIDE, which is a drug marketed by Accord Hlthcare, Amerigen Pharms Ltd, Amneal Pharms, Barr, Chemi Spa, Deva Holding As, Idt Australia Ltd, Lannett Co Inc, Mylan Pharms Inc, Rising Pharms Inc, Sun Pharma Global, Watson Labs Teva, and Zydus Pharms Usa Inc, and is included in thirteen NDAs. It is available from twelve suppliers. Additional details are available on the TEMOZOLOMIDE profile page.

The generic ingredient in TEMOZOLOMIDE is temozolomide. There are sixteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the temozolomide profile page.
Summary for 203898
Tradename:TEMOZOLOMIDE
Applicant:Lannett Co Inc
Ingredient:temozolomide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203898
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 203898
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203898 ANDA Lannett Company, Inc.. 62175-240 N 62175-240-19
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203898 ANDA Lannett Company, Inc.. 62175-240 N 62175-240-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Feb 10, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Feb 10, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Feb 10, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Merck
Colorcon
Daiichi Sankyo
McKinsey
Baxter
Express Scripts
Teva
Cantor Fitzgerald

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