FDA.reportPublic FDA data

Application 070914

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NALBUPHINE HYDROCHLORIDENALBUPHINE HYDROCHLORIDEINJECTABLE;INJECTION10MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9918Nalbuphine HydrochlorideNalbuphine HydrochlorideHenry Schein, Inc.ANDACurrent
0404-9918Nalbuphine HydrochlorideNalbuphine HydrochlorideHenry Schein, Inc.ANDACurrent
0409-1463Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1463Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1463Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1463Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1463Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1463Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1463Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1463Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1463Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1463Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1463Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
52584-463Nalbuphine HydrochlorideNalbuphine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-463Nalbuphine HydrochlorideNalbuphine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-463Nalbuphine HydrochlorideNalbuphine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-463Nalbuphine HydrochlorideNalbuphine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent