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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Boehringer Ingelheim
Federal Trade Commission
Daiichi Sankyo
Deloitte
Merck
Argus Health
Moodys
US Department of Justice
Teva

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201742

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NDA 201742 describes TEMOZOLOMIDE, which is a drug marketed by Accord Hlthcare, Amerigen Pharms Ltd, Amneal Pharms, Barr, Chemi Spa, Deva Holding As, Idt Australia Ltd, Kremers Urban Pharms, 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 fifteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the temozolomide profile page.
Summary for 201742
Tradename:TEMOZOLOMIDE
Applicant:Sun Pharma Global
Ingredient:temozolomide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201742
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 201742
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 201742 ANDA Sun Pharma Global FZE 47335-890 47335-890-75 20 BLISTER PACK in 1 CARTON (47335-890-75) > 1 CAPSULE in 1 BLISTER PACK
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 201742 ANDA Sun Pharma Global FZE 47335-890 47335-890-72 15 BLISTER PACK in 1 CARTON (47335-890-72) > 1 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Feb 12, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Feb 12, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Feb 12, 2014TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Chubb
Cerilliant
Daiichi Sankyo
Deloitte
Healthtrust
QuintilesIMS
Argus Health
Merck
Mallinckrodt

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