← FDA Drug Approvals (Drugs@FDA)
PRUCALOPRIDE SUCCINATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TEVA PHARMS INC · Approved 2026-02-05
Drug application
- FDA Application #
ANDA219071- 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
- TEVA PHARMS INC
- First approval
- 2026-02-05
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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