Danazol

Treats endometriosis amenable. ANDA 77246, held by Lannett Co Inc. Danazol.

As of Nov 14, 2026, ANDA 77246 (Danazol), held by Lannett Co Inc, was first approved by FDA on Sep 28, 2005, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 28, 2005
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Endometriosis. Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management. Hereditary Angioedema. Danazol capsules are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 28, 2005	Original application	Approved	None posted

Products

3 strengths and forms


Danazol200MG · capsule;oral	Danazol	Rx
Danazol50MG · capsule;oral	Danazol	Rx
Danazol100MG · capsule;oral	Danazol	Rx

All 4 submissions, including labeling and manufacturing supplements


Aug 22, 2018	Supplement 14Labeling · Standard review	Approved	None posted
Mar 15, 2012	Supplement 6Labeling	Approved	None posted
Oct 29, 2007	Supplement 4Labeling	Approved	None posted
Sep 28, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 77246
Drugs@FDA: Overview at FDA
Company: Lannett Company

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters