Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 209022

0.093MG Marketing Status: Prescription

Proprietary Name: XHANCE
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: 0.093MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209022
Product Number: 001
Approval Date: Sep 18, 2017
Applicant Holder Full Name: OPTINOSE US INC
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