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Generated: August 17, 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. Six suppliers are listed for this compound. Additional details are available on the tetrabenazine profile page.

Summary for NDA: 021894

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 Inc. 67386-421 67386-421-01 112 TABLET in 1 BOTTLE (67386-421-01)
XENAZINE
tetrabenazine
TABLET;ORAL 021894 NDA Lundbeck Inc. 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 500+ biopharmaceutical companies globally:

Julphar
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Argus Health

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 verifification 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.

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