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Generated: May 24, 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, 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 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 N 47335-890-21
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 201742 ANDA Sun Pharma Global FZE 47335-890 N 47335-890-72

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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