BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Cantor Fitzgerald
Daiichi Sankyo

Generated: January 17, 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, 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 203898
Applicant:Kremers Urban Pharms
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 Kremers Urban Pharmaceuticals Inc. 62175-240 62175-240-24 14 CAPSULE in 1 BOTTLE (62175-240-24)
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203898 ANDA Kremers Urban Pharmaceuticals Inc. 62175-240 62175-240-19 5 CAPSULE in 1 BOTTLE (62175-240-19)

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 leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts

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