← FDA Drug Approvals (Drugs@FDA)
PRUCALOPRIDE SUCCINATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS LIFESCIENCES · Approved 2025-08-07
Drug application
- FDA Application #
ANDA218056
- 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
- ZYDUS LIFESCIENCES
- Manufacturer
- Viona Pharmaceuticals Inc
- First approval
- 2025-08-07
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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