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Generated: May 27, 2017

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Danazol - Generic Drug Details

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What are the generic drug sources for danazol and what is the scope of danazol freedom to operate?

is the generic ingredient in two branded drugs marketed by Lannett, Sanofi Aventis Us, Am Therap, and Barr, and is included in four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for danazol. Four suppliers are listed for this compound.

Summary for Generic Name: danazol

Drug Master File Entries: see list8
Suppliers / Packagers: see list4
Bulk Api Vendors: see list27
Clinical Trials: see list5
Patent Applications: see list4,630
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:danazol at DailyMed

Pharmacology for Ingredient: danazol

Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
CAPSULE;ORAL077246-001Sep 28, 2005ABRXNoNo► Subscribe► Subscribe
CAPSULE;ORAL074582-002May 29, 1998ABRXNoNo► Subscribe► Subscribe
Am Therap
CAPSULE;ORAL071569-001Dec 30, 1987DISCNNoNo► Subscribe► Subscribe
CAPSULE;ORAL077246-003Apr 19, 2007ABRXNoNo► Subscribe► Subscribe
CAPSULE;ORAL074582-003May 29, 1998ABRXNoNo► Subscribe► Subscribe
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