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Generated: January 23, 2019

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Details for New Drug Application (NDA): 208630

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NDA 208630 describes GLEOLAN, which is a drug marketed by Nxdc and is included in one NDA. It is available from one supplier. Additional details are available on the GLEOLAN profile page.

The generic ingredient in GLEOLAN is aminolevulinic acid hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aminolevulinic acid hydrochloride profile page.
Summary for 208630
Tradename:GLEOLAN
Applicant:Nxdc
Ingredient:aminolevulinic acid hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208630
Medical Subject Heading (MeSH) Categories for 208630
Suppliers and Packaging for NDA: 208630
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLEOLAN aminolevulinic acid hydrochloride FOR SOLUTION;ORAL 208630 NDA NX DEVELOPMENT CORP 71469-231 71469-231-01 1 VIAL, SINGLE-DOSE in 1 CARTON (71469-231-01) > 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength1.5GM/VIAL
Approval Date:Jun 6, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 6, 2024
Regulatory Exclusivity Use:OPTICAL IMAGING AGENT INDICATED IN PATIENTS WITH GLIOMA (SUSPECTED WORLD HEALTH ORGANIZATION GRADES III OR IV ON PREOPERATIVE IMAGING) AS AN ADJUNCT FOR THE VISUALIZATION OF MALIGNANT TISSUE DURING SURGERY

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