Application 020006

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MANNITOL 5% IN PLASTIC CONTAINERMANNITOLINJECTABLE;INJECTION5GM/100MLNoNo
002MANNITOL 10% IN PLASTIC CONTAINERMANNITOLINJECTABLE;INJECTION10GM/100MLNoNo
003MANNITOL 15% IN PLASTIC CONTAINERMANNITOLINJECTABLE;INJECTION15GM/100MLNoNo
004MANNITOL 20% IN PLASTIC CONTAINERMANNITOLINJECTABLE;INJECTION20GM/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-7578MannitolMANNITOLB. Braun Medical Inc.NDACurrent
0264-7578MannitolMANNITOLB. Braun Medical Inc.NDACurrent
0264-7578MannitolMANNITOLB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60106SUPPL2019-09-25
60097SUPPL2019-09-25
57332SUPPL2019-01-23
57170SUPPL2019-01-10