FDA.reportPublic FDA data

Application 070918

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NALBUPHINE HYDROCHLORIDENALBUPHINE HYDROCHLORIDEINJECTABLE;INJECTION20MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9917Nalbuphine Hydrochloridenalbuphine hydrochlorideHenry Schein, Inc.ANDACurrent
0404-9917Nalbuphine Hydrochloridenalbuphine hydrochlorideHenry Schein, Inc.ANDACurrent
0409-1467Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1467Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1467Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1467Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1467Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
51662-1418NALBUPHINE HCINALBUPHINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1418NALBUPHINE HCINALBUPHINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-083Nalbuphine Hydrochloridenalbuphine hydrochlorideGeneral Injectables and Vaccines,Inc.ANDACurrent