FDA Orange Book · active-ingredient family
Levofloxacin
Levofloxacin: 5 brands, 43 generics; first approved Dec 20, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 43 ANDA applications approved.
Brands (NDA)
5
Generics (ANDA)
43
Listed patents
0
Presentations
111
Brand (NDA) products
Originator applications
- LEVAQUINRLDJANSSEN PHARMSNDA 0217212004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/10ML SOLUTION ORAL Discontinued - - IQUIXRLDSANTENNDA 0215712004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5% SOLUTION/DROPS OPHTHALMIC Discontinued - - QUIXINRLDSANTENNDA 0211992000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Discontinued - - LEVAQUINRLDJANSSEN PHARMSNDA 02063519965 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE INJECTION Discontinued - EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE INJECTION Discontinued - EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE INJECTION Discontinued - EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE INJECTION Discontinued - EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE INJECTION Discontinued - - LEVAQUINRLDJANSSEN PHARMSNDA 02063419963 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - 500MG TABLET ORAL Discontinued - 750MG TABLET ORAL Discontinued -
Generic (ANDA) products (43)
Abbreviated applications
- KNACKANDA 21616420243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE INJECTION Discontinued - EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE INJECTION Discontinued - EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE INJECTION Discontinued - - GLANDANDA 20690820203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE INJECTION Rx AP EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE INJECTION Rx AP EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE INJECTION Rx AP - LEVOFLOXACINGLANDANDA 20554020202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE INJECTION Rx AP EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE INJECTION Rx AP - LEVOFLOXACINMICRO LABS LTD INDIAANDA 2056002019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5% SOLUTION/DROPS OPHTHALMIC Discontinued - - LEVOFLOXACINHEC PHARMANDA 20496820193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - LEVOFLOXACINLANNETT CO INCANDA 2052222018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/10ML SOLUTION ORAL Rx AA - LEVOFLOXACINPHARMOBEDIENTANDA 2048992017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Discontinued - - LEVOFLOXACINZYDUS PHARMSANDA 20596820172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE INJECTION Discontinued - EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE INJECTION Discontinued - - EUGIA PHARMAANDA 20691920163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE INJECTION Discontinued - EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE INJECTION Discontinued - EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE INJECTION Discontinued - - HOSPIRAANDA 07857920153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE INJECTION Rx AP EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE INJECTION Rx AP EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE INJECTION Rx AP - LEVOFLOXACINHOSPIRAANDA 07857720152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE INJECTION Discontinued - EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE INJECTION Discontinued - - LEVOFLOXACINJUBILANT GENERICSANDA 20361320152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - 500MG TABLET ORAL Discontinued - - LEVOFLOXACINHETERO LABS LTD VANDA 20280120153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - LEVOFLOXACINWATSON LABS INCANDA 20148420133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - 500MG TABLET ORAL Discontinued - 750MG TABLET ORAL Discontinued - - BAXTER HLTHCARE CORPANDA 09139720133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE INJECTION Discontinued - EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE INJECTION Discontinued - EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE INJECTION Discontinued - - FRESENIUS KABI USAANDA 20067420133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE INJECTION Rx AP EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE INJECTION Rx AP EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE INJECTION Rx AP - LEVOFLOXACINBAXTER HLTHCARE CORPANDA 0914362013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE INJECTION Discontinued - - LEVOFLOXACINAVET LIFESCIENCESANDA 20259020132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE INJECTION Discontinued - EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE INJECTION Discontinued - - LEVOFLOXACINEUGIA PHARMAANDA 20232820132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE INJECTION Discontinued - EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE INJECTION Discontinued - - LEVOFLOXACINZYDUS LIFESCIENCESANDA 07765220123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - LEVOFLOXACINCHARTWELL MOLECULARANDA 07689020123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - LEVOFLOXACINMACLEODS PHARMS LTDANDA 20083920123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - LEVOFLOXACINORBION PHARMSANDA 20220020123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - LEVOFLOXACINAPOTEX INCANDA 09078720113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - 500MG TABLET ORAL Discontinued - 750MG TABLET ORAL Discontinued - - HIKMA FARMACEUTICAANDA 09137520113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE INJECTION Rx AP EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE INJECTION Rx AP EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE INJECTION Rx AP - INFORLIFEANDA 09034320113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE INJECTION Rx AP EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE INJECTION Rx AP EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE INJECTION Rx AP - LEVOFLOXACINPHARMOBEDIENTANDA 20056020112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE INJECTION Discontinued - EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE INJECTION Discontinued - - LEVOFLOXACINRSRISINGANDA 09164420112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE INJECTION Rx AP EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE INJECTION Rx AP - LEVOFLOXACINRSNOVITIUM PHARMAANDA 0916782011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/10ML SOLUTION ORAL Rx AA - LEVOFLOXACINAUROBINDO PHARMA LTDANDA 20104320113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - LEVOFLOXACINCHARTWELL RXANDA 09036720113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - 500MG TABLET ORAL Discontinued - 750MG TABLET ORAL Discontinued - - LEVOFLOXACINDR REDDYS LABS INCANDA 07671020113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - LEVOFLOXACINGLENMARK PHARMS LTDANDA 20025020113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - LEVOFLOXACINLUPINANDA 07842420113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - 500MG TABLET ORAL Discontinued - 750MG TABLET ORAL Discontinued - - LEVOFLOXACINNATCO PHARMAANDA 07627620112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - 500MG TABLET ORAL Discontinued - - LEVOFLOXACINNATCO PHARMAANDA 0770972011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - LEVOFLOXACINSANDOZANDA 07743820113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - 500MG TABLET ORAL Discontinued - 750MG TABLET ORAL Discontinued - - LEVOFLOXACINTEVAANDA 07636120113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - LEVOFLOXACINTORRENT PHARMSANDA 09072220113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - 500MG TABLET ORAL Discontinued - 750MG TABLET ORAL Discontinued - - LEVOFLOXACINWATSON LABS TEVAANDA 0768262011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Discontinued - - LEVOFLOXACINRSRISINGANDA 0777002010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Rx AT - LEVOFLOXACINRUBICON RESEARCHANDA 0782822010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Rx AT - LEVOFLOXACINSCIEGEN PHARMSANDA 0902682010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC 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
30 yr 3 mo ago
Most recent approval
2 yr 9 mo ago
Approvals span 1996–2024 across 48 FDA applications.
Brand (NDA) 510%
Generic (ANDA) 4390%
Levofloxacin: 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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