← FDA Drug Approvals (Drugs@FDA)
PHEBURANE
NDA · New Drug Application · Sponsor: MEDUNIK · Approved 2022-06-17
Drug application
- FDA Application #
NDA216513- Application type
- New Drug Application
- Brand name
- PHEBURANE
- Generic name
- SODIUM PHENYLBUTYRATE
- Active ingredients
- SODIUM PHENYLBUTYRATE
- Dosage form
- PELLETS
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- MEDUNIK
- Manufacturer
- Medunik USA
- First approval
- 2022-06-17
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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