FDA.reportPublic FDA data

Application 070172

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEINJECTABLE;INJECTION0.4MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9920Naloxone HydrochlorideNaloxone HydrochlorideHenry Schein, Inc.ANDACurrent
0404-9920Naloxone HydrochlorideNaloxone HydrochlorideHenry Schein, Inc.ANDACurrent
0409-1782Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1782Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1782Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1782Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHospira, Inc.ANDACurrent
51662-1238NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1238NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1238NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1238NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
52584-782Naloxone HydrochlorideNaloxone HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-782Naloxone HydrochlorideNaloxone HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-782Naloxone HydrochlorideNaloxone HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-782Naloxone HydrochlorideNaloxone HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-782Naloxone HydrochlorideNaloxone HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-782Naloxone HydrochlorideNaloxone HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
55154-6998Naloxone HydrochlorideNALOXONE HYDROCHLORIDECardinal HealthANDACurrent
64725-1782Naloxone HydrochlorideNALOXONE HYDROCHLORIDETYA PharmaceuticalsANDACurrent