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RECORLEV

NDA · New Drug Application · Sponsor: STRONGBRIDGE · Approved 2021-12-30

Drug application

FDA Application #

NDA214133

Application type

New Drug Application

Brand name

RECORLEV

Generic name

LEVOKETOCONAZOLE

Active ingredients

LEVOKETOCONAZOLE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

STRONGBRIDGE

Manufacturer

Xeris Pharmaceuticals, Inc.

First approval

2021-12-30

Source

Authoritative

Drugs@FDA application overview

Machine

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