Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
US Army
US Department of Justice
Queensland Health

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206129

« Back to Dashboard

NDA 206129 describes TETRABENAZINE, which is a drug marketed by Actavis Labs Fl Inc, Apicore Us, Bionpharma Inc, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Lupin Ltd, and Sun Pharma Global, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the TETRABENAZINE profile page.

The generic ingredient in TETRABENAZINE is tetrabenazine. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the tetrabenazine profile page.
Summary for 206129
Applicant:Sun Pharma Global
Formulation / Manufacturing:see details
Pharmacology for NDA: 206129
Medical Subject Heading (MeSH) Categories for 206129
Suppliers and Packaging for NDA: 206129
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TETRABENAZINE tetrabenazine TABLET;ORAL 206129 ANDA Sun Pharma Global FZE 47335-179 N 47335-179-23
TETRABENAZINE tetrabenazine TABLET;ORAL 206129 ANDA Sun Pharma Global FZE 47335-277 N 47335-277-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Aug 17, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Aug 17, 2015TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Farmers Insurance
Chinese Patent Office

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 verifification 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.