Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Product Details for NDA 021372

ALOXI (PALONOSETRON HYDROCHLORIDE)
EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)
Marketing Status: Prescription

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)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021372
Product Number: 002
Approval Date: Feb 29, 2008
Applicant Holder Full Name: HELSINN HEALTHCARE SA
Marketing Status: Prescription
Patent and Exclusivity Information

ALOXI (PALONOSETRON HYDROCHLORIDE)
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Marketing Status: Prescription

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)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021372
Product Number: 001
Approval Date: Jul 25, 2003
Applicant Holder Full Name: HELSINN HEALTHCARE SA
Marketing Status: Prescription
Patent and Exclusivity Information