← FDA Drug Approvals (Drugs@FDA)
GLYCEROL PHENYLBUTYRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2021-12-02
Drug application
- FDA Application #
ANDA205742- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- GLYCEROL PHENYLBUTYRATE
- Generic name
- GLYCEROL PHENYLBUTYRATE ORAL
- Active ingredients
- GLYCEROL PHENYLBUTYRATE
- Dosage form
- LIQUID
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PH HEALTH
- Manufacturer
- Par Health USA, LLC
- First approval
- 2021-12-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown