Application 018916

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%HEPARIN SODIUMINJECTABLE;INJECTION1,000 UNITS/100MLNoNo
002HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%HEPARIN SODIUMINJECTABLE;INJECTION10,000 UNITS/100MLNoNo
003HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%HEPARIN SODIUMINJECTABLE;INJECTION5,000 UNITS/100MLNoNo
004HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%HEPARIN SODIUMINJECTABLE;INJECTION100 UNITS/MLNoNo
005HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%HEPARIN SODIUMINJECTABLE;INJECTION10,000 UNITS/100MLNoNo
006HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERHEPARIN SODIUMINJECTABLE;INJECTION5,000 UNITS/100MLNoNo
007HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERHEPARIN SODIUMINJECTABLE;INJECTION5,000 UNITS/100MLNoNo
008HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERHEPARIN SODIUMINJECTABLE;INJECTION10,000 UNITS/100MLNoNo
009HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHEPARIN SODIUMINJECTABLE;INJECTION5,000 UNITS/100MLNoNo
010HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHEPARIN SODIUMINJECTABLE;INJECTION200 UNITS/100MLYesYes
011HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHEPARIN SODIUMINJECTABLE;INJECTION200 UNITS/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-3150Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7620Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7620Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7620Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7620Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7620Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7650Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7650Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7650Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7650Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7650Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7651Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7651Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7651Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7651Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7651Heparin SodiumHEPARIN SODIUMHospira, Inc.NDACurrent
51662-1411HEPARIN SODIUMHEPARIN SODIUMHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1411HEPARIN SODIUMHEPARIN SODIUMHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84321SUPPL 2025-11-26
84241SUPPL 2025-11-21
80563SUPPL 2024-12-13
80552SUPPL 2024-12-11
80009SUPPL 2024-10-28
79995SUPPL 2024-10-25
64167SUPPL2020-08-03
64151SUPPL2020-07-31
59917SUPPL2019-09-05
59910SUPPL2019-09-05
33644SUPPL2016-04-12
33643SUPPL2016-04-12
16090SUPPL2016-04-07
1126SUPPL2016-04-07
33642SUPPL2013-02-14
1125SUPPL2013-02-13
16089SUPPL2011-12-29
11359SUPPL2011-12-23