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SPORANOX

NDA · New Drug Application · Sponsor: JANSSEN PHARMS · Approved 1992-09-11

Drug application

FDA Application #

NDA020083

Application type

New Drug Application

Brand name

SPORANOX

Generic name

ITRACONAZOLE

Active ingredients

ITRACONAZOLE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

JANSSEN PHARMS

Manufacturer

Janssen Pharmaceuticals, Inc.

First approval

1992-09-11

Source

Authoritative

Drugs@FDA application overview

Machine

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