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Serving leading biopharmaceutical companies globally:

US Army
Johnson and Johnson
Argus Health
Federal Trade Commission
Farmers Insurance
Harvard Business School

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021894

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NDA 021894 describes XENAZINE, which is a drug marketed by Valeant Pharms North and is included in one NDA. It is available from two suppliers. Additional details are available on the XENAZINE profile page.

The generic ingredient in XENAZINE 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 021894

Formulation / Manufacturing:see details

Pharmacology for NDA: 021894

Medical Subject Heading (MeSH) Categories for 021894

Suppliers and Packaging for NDA: 021894

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XENAZINE tetrabenazine TABLET;ORAL 021894 NDA Lundbeck Pharmaceuticals LLC 67386-421 67386-421-01 112 TABLET in 1 BOTTLE (67386-421-01)
XENAZINE tetrabenazine TABLET;ORAL 021894 NDA Lundbeck Pharmaceuticals LLC 67386-422 67386-422-01 112 TABLET in 1 BOTTLE (67386-422-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Aug 15, 2008TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Aug 15, 2008TE:ABRLD:Yes

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Federal Trade Commission
Argus Health
Cantor Fitzgerald

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