FDA Orange Book · active-ingredient family
Diazoxide
Diazoxide: 3 brands, 3 generics; first approved Aug 26, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
3
Listed patents
0
Presentations
7
Brand (NDA) products
Originator applications
- TEVA BRANDED PHARMNDA 017453—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML SUSPENSION ORAL Rx AB - TEVA BRANDED PHARMNDA 017425—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — - SCHERINGNDA 016996—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (3)
Abbreviated applications
- DIAZOXIDENOVITIUM PHARMAANDA 2107992020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML SUSPENSION ORAL Rx AB - DIAZOXIDEE5 PHARMA INCANDA 2110502019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML SUSPENSION ORAL Rx AB - DIAZOXIDEABRAXIS PHARMANDA 0715191987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG/ML INJECTABLE INJECTION 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 7 mo ago
Most recent approval
6 yr 3 mo ago
Approvals span 1987–2020 across 6 FDA applications.
Brand (NDA) 350%
Generic (ANDA) 350%
Diazoxide: 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.
