Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

How our clients use DrugPatentWatch

Generated: April 30, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201742

« Back to Dashboard
NDA 201742 describes TEMOZOLOMIDE, which is a drug marketed by Rising Pharms Inc, Idt Australia Ltd, Mylan Pharms Inc, Accord Hlthcare, Chemi Spa, Sun Pharma Global, Barr, Amerigen Pharms Ltd, Amneal Pharms, and Kremers Urban Pharms, and is included in ten 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 NDA: 201742

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
CAPSULE;ORAL 201742 ANDA Sun Pharma Global FZE 47335-890 47335-890-21 1 BOTTLE in 1 CARTON (47335-890-21) > 14 CAPSULE in 1 BOTTLE
CAPSULE;ORAL 201742 ANDA Sun Pharma Global FZE 47335-890 47335-890-74 5 BLISTER PACK in 1 CARTON (47335-890-74) > 1 CAPSULE in 1 BLISTER PACK

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How our clients use DrugPatentWatch

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted

Follow DrugPatentWatch:

Google Plus