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Cipla
Baxter
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US Army
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US Department of Justice
Dow
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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206129

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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
Tradename:TETRABENAZINE
Applicant:Sun Pharma Global
Ingredient:tetrabenazine
Patents:0
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

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
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McKinsey
Chinese Patent Office
Citi
Healthtrust
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Chubb

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