➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Express Scripts

Last Updated: July 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021894

Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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 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
Applicant:Valeant Pharms North
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Johnson and Johnson

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 verification 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.