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Last Updated: April 18, 2024

Danazol - Generic Drug Details


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

Danazol is the generic ingredient in two branded drugs marketed by Am Therap, Barr, Lannett Co Inc, and Sanofi Aventis Us, and is included in four NDAs. 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.

Drug Prices for danazol

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Recent Clinical Trials for danazol

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Beijing Tsinghua Changgeng HospitalPhase 2
Peking University First HospitalPhase 2
Beijing Luhe HospitalPhase 2

See all danazol clinical trials

Pharmacology for danazol
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for danazol

US Patents and Regulatory Information for danazol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us DANOCRINE danazol CAPSULE;ORAL 017557-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Am Therap DANAZOL danazol CAPSULE;ORAL 071569-001 Dec 30, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lannett Co Inc DANAZOL danazol CAPSULE;ORAL 077246-001 Sep 28, 2005 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us DANOCRINE danazol CAPSULE;ORAL 017557-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us DANOCRINE danazol CAPSULE;ORAL 017557-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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