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PRUCALOPRIDE SUCCINATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2026-07-27

Drug application

FDA Application #
ANDA219234
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
ALEMBIC
Manufacturer
Alembic Pharmaceuticals Inc.
First approval
2026-07-27

Source

Authoritative
Drugs@FDA application overview
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