FDA.reportPublic FDA data

Application 205572

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-850MoxifloxacinMOXIFLOXACIN HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
63323-850MoxifloxacinMOXIFLOXACIN HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
63323-850MoxifloxacinMOXIFLOXACIN HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
66298-8507MoxifloxacinMOXIFLOXACIN HYDROCHLORIDEFresenius Kabi Norge ASNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62380SUPPL2020-03-31
62379SUPPL2020-03-31
62360SUPPL2020-03-30
58634SUPPL2019-05-08
58633SUPPL2019-05-08
58593SUPPL2019-05-07
56073SUPPL2018-10-23
56032SUPPL2018-10-19
43982SUPPL2016-07-26
32688SUPPL2016-07-26
19659SUPPL2016-07-26
43493ORIG2016-03-02
24498ORIG2016-03-02
19658ORIG2015-04-10
10466ORIG2015-04-08