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SIRTURO

NDA · New Drug Application · Sponsor: JANSSEN THERAP · Approved 2012-12-28

Drug application

FDA Application #

NDA204384

Application type

New Drug Application

Brand name

SIRTURO

Generic name

BEDAQUILINE FUMARATE

Active ingredients

BEDAQUILINE FUMARATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

JANSSEN THERAP

Manufacturer

Janssen Products, LP

First approval

2012-12-28

Source

Authoritative

Drugs@FDA application overview

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