← FDA DRUG APPROVALS

FDA NDA · NDA210166

MOTEGRITY

prucalopride

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA210166
TYPE
NDA
ORIGINAL APPROVAL
2018-12-14
LATEST ACTION
2025-07-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MOTEGRITY · ReferencePrescription
PRUCALOPRIDE SUCCINATE EQ 2MG BASE · TABLET · ORAL
MOTEGRITY · ReferencePrescription
PRUCALOPRIDE SUCCINATE EQ 1MG BASE · TABLET · ORAL

Approval history

2025-07-10Efficacy · Supplement 4 · standard — Letter ↗AP
2020-11-09Labeling · Supplement 2 · standard — Letter ↗AP
2018-12-14Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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