Application 213407

Type
NDA
Sponsor
NEXUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMERPHEDEPHEDRINE SULFATEINJECTABLE;INJECTION50MG/10MLYesNo
002EMERPHEDEPHEDRINE SULFATESOLUTION;INTRAVENOUS25MG/5ML (5MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
14789-250EmerphedEphedrine SulfateNexus Pharamaceuticals Inc.NDACurrent
14789-250EmerphedEphedrine SulfateNexus Pharamaceuticals Inc.NDACurrent
14789-250EmerphedEphedrine SulfateNexus Pharmaceuticals IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79429SUPPL 2024-08-16
79426SUPPL 2024-08-16
73998SUPPL 2023-04-14
73997SUPPL 2023-04-14
63977ORIG2020-07-21
62607ORIG2020-04-20
62606ORIG2020-04-20