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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Chinese Patent Office
Dow
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Healthtrust
Cantor Fitzgerald
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Mallinckrodt

Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203490

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NDA 203490 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 203490
Tradename:TEMOZOLOMIDE
Applicant:Amerigen Pharms Ltd
Ingredient:temozolomide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203490
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 203490
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203490 ANDA Amerigen Pharmaceuticals Inc. 43975-252 N 43975-252-05
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203490 ANDA Amerigen Pharmaceuticals Inc. 43975-252 N 43975-252-14

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jul 13, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Jul 13, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jul 13, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Queensland Health
Argus Health
Chubb
Healthtrust
Teva
AstraZeneca
Mallinckrodt
Express Scripts

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