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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Department of Justice

Generated: December 14, 2017

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, Hetero Labs Ltd V, and Sun Pharma Global, and is included in four NDAs. It is available from five suppliers. Additional details are available on the TETRABENAZINE profile page.

The generic ingredient in TETRABENAZINE is tetrabenazine. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tetrabenazine profile page.

Summary for 206129

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 47335-179-23 112 TABLET in 1 BOTTLE (47335-179-23)
TETRABENAZINE tetrabenazine TABLET;ORAL 206129 ANDA Sun Pharma Global FZE 47335-277 47335-277-23 112 TABLET in 1 BOTTLE (47335-277-23)

Summary for product number 001

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

Summary for product number 002

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

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Serving leading biopharmaceutical companies globally:

Queensland Health
Express Scripts
US Army
Fish and Richardson

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