Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 208583

XULTOPHY 100/3.6 (INSULIN DEGLUDEC; LIRAGLUTIDE)
300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML) Marketing Status: Prescription

Active Ingredient: INSULIN DEGLUDEC; LIRAGLUTIDE
Proprietary Name: XULTOPHY 100/3.6
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208583
Product Number: 001
Approval Date: Nov 21, 2016
Applicant Holder Full Name: NOVO NORDISK 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