← FDA Drug Approvals (Drugs@FDA)
PRUCALOPRIDE SUCCINATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2025-06-24
Drug application
- FDA Application #
ANDA218295- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PRUCALOPRIDE SUCCINATE
- Generic name
- Prucalopride Succinate
- Active ingredients
- PRUCALOPRIDE SUCCINATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ALKEM LABS LTD
- First approval
- 2025-06-24
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown