Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 205718

AKYNZEO (NETUPITANT; PALONOSETRON HYDROCHLORIDE)
300MG;EQ 0.5MG BASE Marketing Status: Prescription

Active Ingredient: NETUPITANT; PALONOSETRON HYDROCHLORIDE
Proprietary Name: AKYNZEO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG;EQ 0.5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205718
Product Number: 001
Approval Date: Oct 10, 2014
Applicant Holder Full Name: HELSINN HEALTHCARE SA
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English