Last Updated: November 8, 2026

Details for New Drug Application (NDA): 071569

NDA 071569 describes DANAZOL, which is a drug marketed by Am Therap, Barr, and Lannett Co Inc, and is included in three NDAs. It is available from four suppliers. Additional details are available on the DANAZOL profile page.

The generic ingredient in DANAZOL is danazol. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the danazol profile page.

Summary for 071569

Tradename:	DANAZOL
Applicant:	Am Therap
Ingredient:	danazol
Patents:	0

Medical Subject Heading (MeSH) Categories for 071569

Estrogen Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Dec 30, 1987	TE:		RLD:	No

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