FDA.reportPublic FDA data

Application 070916

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
0409-1465Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1465Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1465Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1465Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1465Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
63739-466Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEMcKesson CorporationANDACurrent
63739-466Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEMcKesson Corporation dba SKY PackagingANDACurrent