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Generated: August 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206309

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NDA 206309 describes TEMOZOLOMIDE, which is a drug marketed by Accord Hlthcare, Amerigen Pharms Ltd, Amneal Pharms, Apotex Inc, Barr, Chemi Spa, Deva Holding As, Idt Australia Ltd, Lannett Co Inc, Mylan, Rising, Sun Pharm, Watson Labs Teva, and Zydus Pharms, and is included in fourteen NDAs. It is available from fourteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the temozolomide profile page.
Summary for 206309
Tradename:TEMOZOLOMIDE
Applicant:Rising
Ingredient:temozolomide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206309
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 206309
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 206309 ANDA Rising Pharmaceuticals, Inc. 64980-333 64980-333-05 5 CAPSULE in 1 BOTTLE, PLASTIC (64980-333-05)
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 206309 ANDA Rising Pharmaceuticals, Inc. 64980-333 64980-333-14 14 CAPSULE in 1 BOTTLE, PLASTIC (64980-333-14)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Apr 27, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Apr 27, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Apr 27, 2016TE:ABRLD:No

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