← FDA Drug Approvals (Drugs@FDA)
RAVICTI
NDA · New Drug Application · Sponsor: HORIZON THERAP US · Approved 2013-02-01
Drug application
- FDA Application #
NDA203284- Application type
- New Drug Application
- Brand name
- RAVICTI
- Generic name
- GLYCEROL PHENYLBUTYRATE
- Active ingredients
- GLYCEROL PHENYLBUTYRATE
- Dosage form
- LIQUID
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- HORIZON THERAP US
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- First approval
- 2013-02-01
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown