FDA Orange Book · active-ingredient family
Danazol
Danazol: 1 brand, 3 generics; first approved Dec 30, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
0
Presentations
10
Brand (NDA) products
Originator applications
- SANOFI AVENTIS USNDA 017557—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (3)
Abbreviated applications
- DANAZOLLANNETT CO INCANDA 07724620073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB - DANAZOLBARRANDA 07458219983 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB - DANAZOLAM THERAPANDA 0715691987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
39 yr 2 mo ago
Most recent approval
19 yr 7 mo ago
Approvals span 1987–2007 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Danazol: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
