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Last Updated: November 30, 2021

DrugPatentWatch Database Preview

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. 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. Two 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
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 208630
Generic Entry Date for 208630*:
Constraining patent/regulatory exclusivity:
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
Dosage:
FOR SOLUTION;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Medical Subject Heading (MeSH) Categories for 208630

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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