← FDA Drug Approvals (Drugs@FDA)
PRUCALOPRIDE SUCCINATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SPECGX LLC · Approved 2025-06-24
Drug application
- FDA Application #
ANDA219193
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PRUCALOPRIDE SUCCINATE
- Generic name
- PRUCALOPRIDE
- Active ingredients
- PRUCALOPRIDE SUCCINATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- SPECGX LLC
- Manufacturer
- SpecGx LLC
- First approval
- 2025-06-24
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown