Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021372

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ALOXI (PALONOSETRON HYDROCHLORIDE)
EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: PALONOSETRON HYDROCHLORIDE
Proprietary Name: ALOXI
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021372
Product Number: 002
Approval Date: Feb 29, 2008
Applicant Holder Full Name: HELSINN HEALTHCARE SA
Marketing Status:  Discontinued
Patent and Exclusivity Information

ALOXI (PALONOSETRON HYDROCHLORIDE)
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: PALONOSETRON HYDROCHLORIDE
Proprietary Name: ALOXI
Dosage Form; Route of Administration: 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Strength: EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021372
Product Number: 001
Approval Date: Jul 25, 2003
Applicant Holder Full Name: HELSINN HEALTHCARE SA
Marketing Status:  Discontinued
Patent and Exclusivity Information