Application 019339

Type
NDA
Sponsor
HOSPIRA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERHEPARIN SODIUMINJECTABLE;INJECTION5,000 UNITS/100MLNoNo
002HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERHEPARIN SODIUMINJECTABLE;INJECTION10,000 UNITS/100MLNoNo
003HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERHEPARIN SODIUMINJECTABLE;INJECTION10,000 UNITS/100MLNoNo
004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERHEPARIN SODIUMINJECTABLE;INJECTION5,000 UNITS/100MLNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-4520Heparin Sodium and DextroseHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7793Heparin Sodium and DextroseHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7793Heparin Sodium and DextroseHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7793Heparin Sodium and DextroseHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7793Heparin Sodium and DextroseHEPARIN SODIUMHospira, Inc.NDACurrent
0409-7793Heparin Sodium and DextroseHEPARIN SODIUMHospira, Inc.NDACurrent

Documents

DocumentSubmission typeDate
77424SUPPL 2024-02-08
77419SUPPL 2024-02-07
59918SUPPL2019-09-05
59911SUPPL2019-09-05
57002SUPPL2018-12-21
56964SUPPL2018-12-21
11478SUPPL2014-03-19
17361SUPPL2014-03-18
17360SUPPL2011-12-29
33726SUPPL2011-12-23
17359SUPPL2009-07-31
1288SUPPL2008-10-21