moxifloxacin Injection

Brand(s)
Avelox
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2015-04-16)
Oldest Current Product
2015-03-18
License(s)
NDA
RxNORM
INJECTION\MOXIFLOXACIN
FDAOB
IV (INFUSION)\INJECTION\MOXIFLOXACIN HYDROCHLORIDE\rdfq
IV (INFUSION)\SOLUTION\MOXIFLOXACIN HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\MOXIFLOXACIN HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\MOXIFLOXACIN

product(s) by strength(s)

250 ml moxifloxacin 1.6 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230850NDAApp Pharmaceuticals, Llc2015-03-18MOXIFLOXACIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA205572a4e28b09-714b-46e7-b4e6-0163cad78fc5

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021277AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINERBAYER HEALTHCARE PHARMACEUTICALS INC2001-11-30p6548079, METHOD OF COMBATING BACTERIA IN A PATIENT, SUBSTANCE
p5849752, METHOD OF COMBATING BACTERIA IN A PATIENT
NDA021277_001
2NDA205572MOXIFLOXACIN HYDROCHLORIDEFRESENIUS KABI USA LLC2015-04-03NDA205572_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA021277_001RXMOXIFLOXACIN HYDROCHLORIDE (160MG/100ML)INJECTIONTrue2001-11-30AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
2NDA205572_001RXMOXIFLOXACIN HYDROCHLORIDE (EQ 400MG BASE/250ML)SOLUTIONTrue2015-04-03MOXIFLOXACIN HYDROCHLORIDE

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5849752 (view patent)2016-12-05NDA021277, NDA021085moxifloxacin Oral Tablet
2p6548079 (view patent)2020-07-25NDA021277

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
156b4f979-bf20-4908-9d7c-5536221d77f8 (view SPL)These highlights do not include all the information needed to use AVELOX safely and effectively. See full prescribing information for AVELOX AVELOX (moxifloxacin hydrochloride) tablets, for oral useAVELOX (moxifloxacin hydrochloride) injection, for intravenous use Initial U.S. Approval: 1999prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.MANUFACTURE2016-05-3026000851733, 000851737moxifloxacin Oral Tablet
2a4e28b09-714b-46e7-b4e6-0163cad78fc5 (view SPL)These highlights do not include all the information needed to use MOXIFLOXACIN safely and effectively. See full prescribing information forMOXIFLOXACIN. MOXIFLOXACINInjection, forintravenous useInitial U.S. Approval: 1999 To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin injection and other antibacterial drugs, moxifloxacin injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-04-161633230850

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII