FDA.reportPublic FDA data

Application 070915

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
0404-9919Nalbuphine Hydrochloridenalbuphine hydrochlorideHenry Schein, Inc.ANDACurrent
0404-9919Nalbuphine Hydrochloridenalbuphine hydrochlorideHenry Schein, Inc.ANDACurrent
0409-1464Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1464Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1464Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1464Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1464Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.ANDACurrent
51662-1420NALBUPHINE HCINALBUPHINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1420NALBUPHINE HCINALBUPHINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-464Nalbuphine Hydrochloridenalbuphine hydrochlorideGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-464Nalbuphine Hydrochloridenalbuphine hydrochlorideGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-464Nalbuphine Hydrochloridenalbuphine hydrochlorideGeneral Injectables and Vaccines, Inc.ANDACurrent
71872-7114Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEMedical Purchasing Solutions, LLCANDACurrent
71872-7114Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEMedical Purchasing Solutions, LLCANDACurrent