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CYSTADANE

NDA · New Drug Application · Sponsor: RECORDATI RARE · Approved 1996-10-25

Drug application

FDA Application #

NDA020576

Application type

New Drug Application

Brand name

CYSTADANE

Generic name

BETAINE

Active ingredients

BETAINE

Dosage form

FOR SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

RECORDATI RARE

Manufacturer

Recordati Rare Diseases

First approval

1996-10-25

Source

Authoritative

Drugs@FDA application overview

Machine

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