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ACAMPROSATE CALCIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BIONPHARMA · Approved 2025-09-18

Drug application

FDA Application #

ANDA219904

Application type

Abbreviated New Drug Application (Generic)

Brand name

ACAMPROSATE CALCIUM

Generic name

ACAMPROSATE CALCIUM

Active ingredients

ACAMPROSATE CALCIUM

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

BIONPHARMA

Manufacturer

Bionpharma Inc.,

First approval

2025-09-18

Source

Authoritative

Drugs@FDA application overview

Machine

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