← FDA Drug Approvals (Drugs@FDA)
SODIUM PHENYLBUTYRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLENMARK PHARMS LTD · Approved 2022-11-01
Drug application
- FDA Application #
ANDA216462- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- SODIUM PHENYLBUTYRATE
- Generic name
- SODIUM PHENYLBUTYRATE
- Active ingredients
- SODIUM PHENYLBUTYRATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- GLENMARK PHARMS LTD
- Manufacturer
- GLENMARK PHARMACEUTICALS INC., USA
- First approval
- 2022-11-01
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown