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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 021372


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NDA 021372 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. Nineteen suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.
Summary for 021372
Tradename:ALOXI
Applicant:Helsinn Hlthcare
Ingredient:palonosetron hydrochloride
Patents:13
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021372
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372 NDA AUTHORIZED GENERIC Cipla USA Inc. 69097-927 69097-927-35 1 VIAL in 1 CARTON (69097-927-35) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrengthEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jul 25, 2003TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jul 30, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try a TrialPatent Expiration:Jul 30, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try a TrialPatent Expiration:Jul 30, 2024Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021372

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 ⤷  Try a Trial ⤷  Try a Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 ⤷  Try a Trial ⤷  Try a Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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