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ACTIVE SUBSTANCE / INN

LEVOFLOXACIN

Brand name(s): LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVAQUIN, LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, Quinsair, LEVOFLOXACIN, IQUIX, LEVOFLOXACIN; DEXTROSE, QUIXIN
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA078767
NDA020635
ACTIVE SUBSTANCE
Levofloxacin
REGULATORS
FDA · EMA
SPONSORS / MAH
JANSSEN PHARMS, EUGIA PHARMA, Chiesi Farmaceutici S.p.A
TOTAL APPLICATIONS
11
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
LEVOFLOXACINANDA091436BAXTER HLTHCARE CORPDiscontinued
LEVOFLOXACINANDA202200ORBION PHARMSPrescription
LEVAQUINNDA021721JANSSEN PHARMSDiscontinued
LEVOFLOXACIN; DEXTROSEANDA090305BEDFORD LABSNone (Tentative Approval)
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERANDA206908GLANDPrescription
LEVOFLOXACINANDA078767HIKMA PHARMSNone (Tentative Approval)
IQUIXNDA021571SANTENDiscontinued
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERANDA206919EUGIA PHARMADiscontinued
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINERNDA020635JANSSEN PHARMSDiscontinued
QUIXINNDA021199SANTENDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
QuinsairChiesi Farmaceutici S.p.AAuthorised25/03/2015Cystic Fibrosis;Respiratory Tract Infections

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