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Generated: September 23, 2018

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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 Accord Hlthcare, Amerigen Pharms Ltd, Amneal Pharms, Apotex Inc, Barr, Chemi Spa, Deva Holding As, Idt Australia Ltd, Lannett Co Inc, Mylan Pharms Inc, Rising Pharms, Sun Pharma Global, Watson Labs Teva, and Zydus Pharms Usa Inc, and is included in fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the temozolomide profile page.
Summary for 078879
Tradename:TEMOZOLOMIDE
Applicant:Barr
Ingredient:temozolomide
Patents:0
Formulation / Manufacturing:see details
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
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 078879 ANDA Teva Pharmaceuticals USA, Inc. 0093-7599 0093-7599-41 14 CAPSULE in 1 BOTTLE (0093-7599-41)
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 078879 ANDA Teva Pharmaceuticals USA, Inc. 0093-7599 0093-7599-57 5 CAPSULE in 1 BOTTLE (0093-7599-57)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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