FDA Orange Book · active-ingredient family
Norfloxacin
Norfloxacin: 2 brands, 0 generics; first approved Oct 31, 1986.
Brand onlyHas discontinued products
Generic status & protection
No listed patents or exclusivity — brand product(s) only.
Brands (NDA)
2
Generics (ANDA)
0
Listed patents
0
Presentations
2
Originator applications
Brand (NDA) products
NOROXINRLDMERCKNDA 0193841986
NOROXINRLD
MERCKNDA 0193841986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | ORAL | Discontinued | — |
MERCKNDA 0197571991
MERCKNDA 0197571991
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.3% | SOLUTION/DROPS | OPHTHALMIC | Discontinued | — |
Orange Book patent file
Listed patents
Listed patents
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.
FDA approval span
Approval history
First approval
Oct 31, 1986
40 yr 3 mo ago
Most recent approval
Jun 17, 1991
35 yr 7 mo ago
Approvals span 1986–1991 across 2 FDA applications.
Brand (NDA) 2100%
Generic (ANDA) 00%
Norfloxacin — 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 BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
