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Details for New Drug Application (NDA): 022233

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NDA 022233 describes ALOXI, which is a drug marketed by Helsinn Hlthcare and is included in two NDAs. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the ALOXI profile page.

The generic ingredient in ALOXI is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. There are five tentative approvals for this compound. Additional details are available on the palonosetron hydrochloride profile page.

Summary for NDA: 022233

Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 22, 2008TE:RLD:Yes

Expired Orange Book Patents for NDA: 022233

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Helsinn Hlthcare
palonosetron hydrochloride
CAPSULE;ORAL022233-001Aug 22, 20085,202,333► Subscribe
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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.