Gatifloxacin
Gatifloxacin: 2 brands, 6 generics; first approved Mar 28, 2003; generic available.
Generic available: 6 ANDA applications approved.
Brand (NDA) products
Generic (ANDA) products (6)
- GATIFLOXACINCAPLINANDA 2135422021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Rx AT - GATIFLOXACINRISINGANDA 2064462018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Discontinued - - GATIFLOXACINSANDOZANDA 2042272016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Rx AT - GATIFLOXACINHIKMAANDA 2031892014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Discontinued - - GATIFLOXACINLUPINANDA 2026532013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Discontinued - - GATIFLOXACINAPOTEX INCANDA 0790842011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.3% SOLUTION/DROPS OPHTHALMIC Discontinued -
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.
Approval history
Approvals span 2003–2021 across 8 FDA applications.
Gatifloxacin: 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.
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