FDA.reportPublic FDA data

Application 211673

Type
NDA
Sponsor
NABRIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XENLETALEFAMULIN ACETATESOLUTION;INTRAVENOUSEQ 150MG BASE/15ML (EQ 10MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72000-030Citric Buffered Normal Salineanhydrous citric acidNabriva Therapeutics US, Inc.NDACurrent
72000-030Citric Buffered Normal Salineanhydrous citric acidNabriva Therapeutics US, Inc.NDACurrent
72000-030Citric Buffered Normal Salineanhydrous citric acidNabriva Therapeutics US, Inc.NDACurrent
72000-030Citric Buffered Normal Salineanhydrous citric acidNabriva Therapeutics US, Inc.NDACurrent
72000-030Citric Buffered Normal Salineanhydrous citric acidNabriva Therapeutics US, Inc.NDACurrent
72000-120Xenletalefamulin acetateNabriva Therapeutics US, Inc.NDACurrent
72000-120Xenletalefamulin acetateNabriva Therapeutics US, Inc.NDACurrent
72000-120Xenletalefamulin acetateNabriva Therapeutics US, Inc.NDACurrent
72000-120Xenletalefamulin acetateNabriva Therapeutics US, Inc.NDACurrent
72000-120Xenletalefamulin acetateNabriva Therapeutics US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66808SUPPL2021-03-18
66800SUPPL2021-03-17
64890SUPPL2020-10-13
60178ORIG2019-09-26
59770ORIG2019-08-20
59767ORIG2019-08-20