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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 021894


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NDA 021894 describes XENAZINE, which is a drug marketed by Bausch 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 twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the tetrabenazine profile page.
Summary for 021894
Tradename:XENAZINE
Applicant:Bausch
Ingredient:tetrabenazine
Patents:0
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)

Profile for product number 001

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

Profile for product number 002

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

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