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Details for New Drug Application (NDA): 078879

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NDA 078879 describes TEMOZOLOMIDE, which is a drug marketed by Lotus Pharm Co Ltd, Idt Australia Ltd, Mylan Pharms Inc, Sun Pharma Global, Barr, Amerigen Pharms Ltd, Amneal Pharms, and Kremers Urban Pharms, and is included in eight NDAs. It is available from nine 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. Twelve suppliers are listed for this compound. Additional details are available on the temozolomide profile page.

Summary for NDA: 078879


Pharmacology for NDA: 078879

Mechanism of ActionAlkylating Activity

Suppliers and Packaging for NDA: 078879

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 078879 ANDA Teva Pharmaceuticals USA Inc 0093-7599 0093-7599-41 14 CAPSULE in 1 BOTTLE (0093-7599-41)
CAPSULE;ORAL 078879 ANDA Teva Pharmaceuticals USA Inc 0093-7599 0093-7599-57 5 CAPSULE in 1 BOTTLE (0093-7599-57)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Mar 1, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Mar 1, 2010TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Mar 1, 2010TE:ABRLD:No

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