FDA.reportPublic FDA data

Application 208609

Type
NDA
Sponsor
AKORN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPHEDRINE SULFATEEPHEDRINE SULFATESOLUTION;INTRAVENOUS50MG/ML (50MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-415Ephedrine SulfateEphedrine SulfateAkornNDACurrent
17478-415Ephedrine SulfateEphedrine SulfateAkorn, Inc.NDACurrent
17478-415Ephedrine SulfateEphedrine SulfateAkornNDACurrent
17478-415Ephedrine SulfateEphedrine SulfateAkorn, Inc.NDACurrent
17478-415Ephedrine SulfateEphedrine SulfateAkorn, Inc.NDACurrent
17478-415Ephedrine SulfateEphedrine SulfateAkorn, Inc.NDACurrent
17478-415Ephedrine SulfateEphedrine SulfateAkornNDACurrent
17478-517Ephedrine SulfateEphedrine SulfateAkorn, Inc.NDACurrent
17478-517Ephedrine SulfateEphedrine SulfateAkorn, Inc.NDACurrent
17478-517Ephedrine SulfateEphedrine SulfateAkorn, Inc.NDACurrent
17478-517Ephedrine SulfateEphedrine SulfateAkorn, Inc.NDACurrent
17478-517Ephedrine SulfateEphedrine SulfateAkornNDACurrent
17478-517Ephedrine SulfateEphedrine SulfateAkornNDACurrent
17478-517Ephedrine SulfateEphedrine SulfateAkornNDACurrent
17478-955Ephedrine SulfateEphedrine SulfateAkornNDACurrent
17478-955Ephedrine SulfateEphedrine SulfateAkorn, Inc.NDACurrent
17478-955Ephedrine SulfateEphedrine SulfateAkorn, Inc.NDACurrent
17478-955Ephedrine SulfateEphedrine SulfateAkornNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78772SUPPL 2024-06-12
78765SUPPL 2024-06-11
73436SUPPL 2023-02-09
52882ORIG2018-03-09
47462ORIG2017-03-03
47386ORIG2017-03-02