FDA.reportPublic FDA data

Application 019952

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERHEPARIN SODIUMINJECTABLE;INJECTION4,000 UNITS/100MLYesYes
004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERHEPARIN SODIUMINJECTABLE;INJECTION5,000 UNITS/100MLYesYes
005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERHEPARIN SODIUMINJECTABLE;INJECTION10,000 UNITS/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-9567Heparin Sodium in DextroseHeparin Sodium and DextroseB. Braun Medical Inc.NDACurrent
0264-9567Heparin Sodium in DextroseHeparin Sodium and DextroseB. Braun Medical Inc.NDACurrent
0264-9567Heparin Sodium in DextroseHeparin Sodium and DextroseB. Braun Medical Inc.NDACurrent
0264-9577Heparin Sodium in DextroseHeparin Sodium and DextroseB. Braun Medical Inc.NDACurrent
0264-9577Heparin Sodium in DextroseHeparin Sodium and DextroseB. Braun Medical Inc.NDACurrent
0264-9577Heparin Sodium in DextroseHeparin Sodium and DextroseB. Braun Medical Inc.NDACurrent
0264-9587Heparin Sodium in DextroseHeparin Sodium and DextroseB. Braun Medical Inc.NDACurrent
0264-9587Heparin Sodium in DextroseHeparin Sodium and DextroseB. Braun Medical Inc.NDACurrent
0264-9587Heparin Sodium in DextroseHeparin Sodium and DextroseB. Braun Medical Inc.NDACurrent
50090-4537Heparin Sodium in DextroseHeparin Sodium and DextroseA-S Medication SolutionsNDACurrent
50090-4537Heparin Sodium in DextroseHeparin Sodium and DextroseA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74754SUPPL 2023-07-13
74746SUPPL 2023-07-13
56426SUPPL2018-11-13
12096SUPPL2016-06-01
19885SUPPL2016-05-27
34138SUPPL2013-09-09
19884SUPPL2013-09-04
34137SUPPL2013-01-11
1849SUPPL2013-01-11
19883SUPPL2011-12-29
34136SUPPL2011-12-23
34135SUPPL2009-03-17
1848SUPPL2004-04-20