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GLEOLAN

NDA · New Drug Application · Sponsor: NXDC · Approved 2017-06-06

Drug application

FDA Application #

NDA208630

Application type

New Drug Application

Brand name

GLEOLAN

Generic name

AMINOLEVULINIC ACID HYDROCHLORIDE

Active ingredients

AMINOLEVULINIC ACID HYDROCHLORIDE

Dosage form

FOR SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

NXDC

Manufacturer

Medexus Pharma, Inc.

First approval

2017-06-06

Source

Authoritative

Drugs@FDA application overview

Machine

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