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DIFICID

NDA · New Drug Application · Sponsor: CUBIST PHARMS LLC · Approved 2020-01-24

Drug application

FDA Application #

NDA213138

Application type

New Drug Application

Brand name

DIFICID

Generic name

FIDAXOMICIN

Active ingredients

FIDAXOMICIN

Dosage form

FOR SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

CUBIST PHARMS LLC

Manufacturer

Merck Sharp & Dohme LLC

First approval

2020-01-24

Source

Authoritative

Drugs@FDA application overview

Machine

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