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. Twenty-one 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

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:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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, 2003	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 30, 2024	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Jul 30, 2024	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Jul 30, 2024	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021372

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

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