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PRUCALOPRIDE SUCCINATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2024-12-26

Drug application

FDA Application #

ANDA218492

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

NOVITIUM PHARMA

Manufacturer

ANI Pharmaceuticals, Inc.

First approval

2024-12-26

Source

Authoritative

Drugs@FDA application overview

Machine

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