FDA.reportPublic FDA data

Application 213994

Type
NDA
Sponsor
NEVAKAR INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPHEDRINE SULFATEEPHEDRINE SULFATEINJECTABLE;INJECTION5MG/MLYesNo
002EPHEDRINE SULFATEEPHEDRINE SULFATESOLUTION;INTRAVENOUS25MG/5ML (5MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42023-243EPHEDRINE SULFATEEphedrine SulfatePar Pharmaceutical, Inc.NDACurrent
42023-243EPHEDRINE SULFATEEphedrine SulfatePar Pharmaceutical, Inc.NDACurrent
42023-253EPHEDRINE SULFATEEphedrine SulfatePar Pharmaceutical, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71192SUPPL2022-06-01
65217ORIG2020-11-13
64943ORIG2020-10-20