Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
Boehringer Ingelheim
Accenture
Queensland Health
US Department of Justice
Farmers Insurance
Colorcon
Moodys

Generated: November 13, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208630

« Back to Dashboard

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
Ingredient-typePorphyrinogens
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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Daiichi Sankyo
US Army
US Department of Justice
Julphar
Healthtrust
QuintilesIMS
Johnson and Johnson
Covington

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.