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FDA Orange Book · active-ingredient family

Levofloxacin

Levofloxacin is approved as 5 brand and 43 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LEVAQUIN · NDA 021721

5

Brand (NDA)

43

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution, solution/drops, tablet

ProductApplicantApplicationTEApproved
LEVAQUINRLDJANSSEN PHARMSNDA 021721—Oct 21, 2004
IQUIXRLDSANTENNDA 021571—Mar 01, 2004
QUIXINRLDSANTENNDA 021199—Aug 18, 2000
LEVAQUINRLD×5JANSSEN PHARMSNDA 020635—Dec 20, 1996
LEVAQUINRLD×3JANSSEN PHARMSNDA 020634—Dec 20, 1996

Generic (ANDA) products (43)

ProductApplicantApplicationTEApproved
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER×3KNACKANDA 216164—Jan 29, 2024
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER×3GLANDANDA 206908APDec 30, 2020
LEVOFLOXACIN×2GLANDANDA 205540APApr 22, 2020
LEVOFLOXACINMICRO LABS LTD INDIAANDA 205600—Feb 27, 2019
LEVOFLOXACIN×3HEC PHARMANDA 204968ABFeb 05, 2019
LEVOFLOXACINLANNETT CO INCANDA 205222AAMay 25, 2018
LEVOFLOXACINPHARMOBEDIENTANDA 204899—Dec 08, 2017
LEVOFLOXACIN×2ZYDUS PHARMSANDA 205968—Jun 01, 2017
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER×3EUGIA PHARMAANDA 206919—Feb 10, 2016
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER×3HOSPIRAANDA 078579APSep 03, 2015
LEVOFLOXACIN×2HOSPIRAANDA 078577—Aug 12, 2015
LEVOFLOXACIN×2JUBILANT GENERICSANDA 203613—Jun 19, 2015
LEVOFLOXACIN×3HETERO LABS LTD VANDA 202801ABJan 08, 2015
LEVOFLOXACIN×3WATSON LABS INCANDA 201484—Nov 22, 2013
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER×3BAXTER HLTHCARE CORPANDA 091397—Aug 08, 2013
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER×3FRESENIUS KABI USAANDA 200674APJun 19, 2013
LEVOFLOXACINBAXTER HLTHCARE CORPANDA 091436—Jun 05, 2013
LEVOFLOXACIN×2AVET LIFESCIENCESANDA 202590—Jan 24, 2013
LEVOFLOXACIN×2EUGIA PHARMAANDA 202328—Jan 24, 2013
LEVOFLOXACIN×3ZYDUS LIFESCIENCESANDA 077652ABSep 07, 2012
LEVOFLOXACIN×3CHARTWELL MOLECULARANDA 076890ABMar 30, 2012
LEVOFLOXACIN×3MACLEODS PHARMS LTDANDA 200839ABMar 22, 2012
LEVOFLOXACIN×3ORBION PHARMSANDA 202200ABJan 30, 2012
LEVOFLOXACIN×3APOTEX INCANDA 090787—Sep 29, 2011
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER×3HIKMA FARMACEUTICAANDA 091375APSep 16, 2011
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER×3INFORLIFEANDA 090343APJul 07, 2011
LEVOFLOXACIN×2PHARMOBEDIENTANDA 200560—Jun 20, 2011
LEVOFLOXACIN×2RISINGANDA 091644APJun 20, 2011
LEVOFLOXACINNOVITIUM PHARMAANDA 091678AAJun 20, 2011
LEVOFLOXACIN×3AUROBINDO PHARMA LTDANDA 201043ABJun 20, 2011
LEVOFLOXACIN×3CHARTWELL RXANDA 090367—Jun 20, 2011
LEVOFLOXACIN×3DR REDDYS LABS INCANDA 076710ABJun 20, 2011
LEVOFLOXACIN×3GLENMARK PHARMS LTDANDA 200250ABJun 20, 2011
LEVOFLOXACIN×3LUPINANDA 078424—Jun 20, 2011
LEVOFLOXACIN×2NATCO PHARMAANDA 076276—Jun 20, 2011
LEVOFLOXACINNATCO PHARMAANDA 077097—Jun 20, 2011
LEVOFLOXACIN×3SANDOZANDA 077438—Jun 20, 2011
LEVOFLOXACIN×3TEVAANDA 076361ABJun 20, 2011
LEVOFLOXACIN×3TORRENT PHARMSANDA 090722—Jun 20, 2011
LEVOFLOXACINWATSON LABS TEVAANDA 076826—Feb 10, 2011
LEVOFLOXACINRISINGANDA 077700ATDec 20, 2010
LEVOFLOXACINRUBICON RESEARCHANDA 078282ATDec 20, 2010
LEVOFLOXACINSCIEGEN PHARMSANDA 090268—Dec 20, 2010

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.

Levofloxacin — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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