FDA.reportPublic FDA data

Application 211672

Type
NDA
Sponsor
NABRIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XENLETALEFAMULIN ACETATETABLET;ORALEQ 600MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72000-110Xenletalefamulin acetateNabriva Therapeutics US, Inc.NDACurrent
72000-110Xenletalefamulin acetateNabriva Therapeutics US, Inc.NDACurrent
72000-110Xenletalefamulin acetateNabriva Therapeutics US, Inc.NDACurrent
72000-110Xenletalefamulin acetateNabriva Therapeutics US, Inc.NDACurrent
72000-110Xenletalefamulin acetateNabriva Therapeutics US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66807SUPPL2021-03-18
66799SUPPL2021-03-17
64889SUPPL2020-10-13
60112ORIG2019-09-26
59769ORIG2019-08-20
59768ORIG2019-08-20