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PRUCALOPRIDE SUCCINATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AJANTA PHARMA LTD · Approved 2026-01-16

Drug application

FDA Application #

ANDA219220

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

AJANTA PHARMA LTD

Manufacturer

Ajanta Pharma USA Inc.

First approval

2026-01-16

Source

Authoritative

Drugs@FDA application overview

Machine

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