Application 209784

Type
ANDA
Sponsor
SANDOZ 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
0781-3269Ephedrine SulfateEphedrine SulfateSandoz IncANDACurrent
0781-3269Ephedrine SulfateEphedrine SulfateSandoz IncANDACurrent
0781-3269Ephedrine SulfateEphedrine SulfateSandoz IncANDACurrent
0781-3269Ephedrine SulfateEphedrine SulfateSandoz IncANDACurrent
0781-3269Ephedrine SulfateEphedrine SulfateSandoz IncANDACurrent
0781-3269Ephedrine SulfateEphedrine SulfateSandoz IncANDACurrent
72572-150Ephedrine SulfateEphedrine SulfateCivica, Inc.ANDACurrent
72572-150Ephedrine SulfateEphedrine SulfateCivica, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49689ORIG2017-09-07