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PRUCALOPRIDE SUCCINATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SOMERSET THERAP · Approved 2025-06-24

Drug application

FDA Application #

ANDA219078

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

SOMERSET THERAP

Manufacturer

Somerset Therapeutics, LLC

First approval

2025-06-24

Source

Authoritative

Drugs@FDA application overview

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