U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 207963

PALONOSETRON HYDROCHLORIDE (PALONOSETRON HYDROCHLORIDE)
EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)
Marketing Status: Discontinued
Active Ingredient: PALONOSETRON HYDROCHLORIDE
Proprietary Name: PALONOSETRON HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N207963
Product Number: 001
Approval Date: Aug 22, 2016
Applicant Holder Full Name: HIKMA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top