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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 017588


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NDA 017588 describes GLEOSTINE, which is a drug marketed by Azurity and is included in one NDA. It is available from two suppliers. Additional details are available on the GLEOSTINE profile page.

The generic ingredient in GLEOSTINE is lomustine. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lomustine profile page.
Summary for 017588
Tradename:GLEOSTINE
Applicant:Azurity
Ingredient:lomustine
Patents:0
Pharmacology for NDA: 017588
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 017588
Antineoplastic Agents, Alkylating
Suppliers and Packaging for NDA: 017588
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLEOSTINE lomustine CAPSULE;ORAL 017588 NDA Azurity Pharmaceuticals, Inc. 24338-340 24338-340-05 1 BOTTLE in 1 CARTON (24338-340-05) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE
GLEOSTINE lomustine CAPSULE;ORAL 017588 NDA Azurity Pharmaceuticals, Inc. 24338-341 24338-341-05 1 BOTTLE in 1 CARTON (24338-341-05) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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