Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 203284

RAVICTI (GLYCEROL PHENYLBUTYRATE)
1.1GM/ML Marketing Status: Prescription

Active Ingredient: GLYCEROL PHENYLBUTYRATE
Proprietary Name: RAVICTI
Dosage Form; Route of Administration: LIQUID; ORAL
Strength: 1.1GM/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203284
Product Number: 001
Approval Date: Feb 1, 2013
Applicant Holder Full Name: HORIZON 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