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CEDAX

NDA · New Drug Application · Sponsor: BURKE THERAP · Approved 1995-12-20

Drug application

FDA Application #

NDA050686

Application type

New Drug Application

Brand name

CEDAX

Generic name

Ceftibuten Dihydrate

Active ingredients

CEFTIBUTEN DIHYDRATE

Dosage form

FOR SUSPENSION

Route

ORAL

Marketing status

Discontinued

Sponsor

BURKE THERAP

First approval

1995-12-20

Source

Authoritative

Drugs@FDA application overview

Machine

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