Details for New Drug Application (NDA): 017588

NDA 017588 describes GLEOSTINE, which is a drug marketed by Latina Pharma and is included in one NDA. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the lomustine profile page.

Summary for 017588

Tradename:	GLEOSTINE
Applicant:	Latina Pharma
Ingredient:	lomustine
Patents:	0

Pharmacology for NDA: 017588

Mechanism of Action

Alkylating 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	NextSource Biotechnology, LLC	58181-3040	58181-3040-5	1 BOTTLE in 1 CARTON (58181-3040-5) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE
GLEOSTINE	lomustine	CAPSULE;ORAL	017588	NDA	NextSource Biotechnology, LLC	58181-3041	58181-3041-5	1 BOTTLE in 1 CARTON (58181-3041-5) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	40MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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