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Last Updated: January 19, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206750

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NDA 206750 describes TEMOZOLOMIDE, which is a drug marketed by Accord Hlthcare, Amerigen Pharms Ltd, Amneal Pharms, Anda Repository, Apotex Inc, Barr, Chemi Spa, Deva Holding As, Idt Australia Ltd, Lannett Co Inc, Mylan, Sun Pharm, Watson Labs Teva, and Zydus Pharms, and is included in fourteen NDAs. It is available from eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the temozolomide profile page.
Summary for 206750
Tradename:TEMOZOLOMIDE
Applicant:Zydus Pharms
Ingredient:temozolomide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206750
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 206750
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 206750 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-751 68382-751-67 14 CAPSULE in 1 BOTTLE (68382-751-67)
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 206750 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-751 68382-751-96 5 CAPSULE in 1 BOTTLE (68382-751-96)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jul 31, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Jul 31, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jul 31, 2017TE:ABRLD:No

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