➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
McKesson
Boehringer Ingelheim
Medtronic
Colorcon

Last Updated: September 29, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078879

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 078879 describes TEMOZOLOMIDE, which is a drug marketed by Accord Hlthcare, Amerigen Pharms Ltd, Amneal Pharms, Apotex Inc, Barr, Chartwell, Chemi Spa, Deva Holding As, Lannett Co Inc, Mylan, Rising, 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. Thirteen 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

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Dow
McKesson
Express Scripts
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.