FDA Orange Book · active-ingredient family
Cinoxacin
Cinoxacin: 1 brand, 2 generics; first approved Feb 28, 1992; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
0
Presentations
4
Brand (NDA) products
Originator applications
- LILLYNDA 018067—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (2)
Abbreviated applications
- CINOXACINTEVAANDA 0730051992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — - CINOXACINTEVAANDA 0730061992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG 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
35 yr ago
Most recent approval
35 yr ago
All 3 applications were approved in 1992.
Brand (NDA) 133%
Generic (ANDA) 267%
Cinoxacin: 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.
