Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 208685

Marketing Status: Prescription
Active Ingredient: DEFLAZACORT
Proprietary Name: EMFLAZA
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 22.75MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208685
Product Number: 001
Approval Date: Feb 9, 2017
Applicant Holder Full Name: PTC THERAPEUTICS 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