FDA.reportPublic FDA data

Application 062420

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GENTAMICIN SULFATEGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 10MG BASE/MLNoNo
002GENTAMICIN SULFATEGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 40MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9865Gentamicin SulfateGentamicin SulfateHenry Schein, Inc.ANDACurrent
0404-9865Gentamicin SulfateGentamicin SulfateHenry Schein, Inc.ANDACurrent
0409-1207Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.ANDACurrent
0409-1207Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.ANDACurrent
0409-1207Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.ANDACurrent
0409-1207Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.ANDACurrent
0409-1207Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.ANDACurrent
0409-1207Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.ANDACurrent
0409-1207Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.ANDACurrent
0409-1207Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.ANDACurrent
0409-1207Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.ANDACurrent
0409-1207Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.ANDACurrent
51662-1597GENTAMICIN SULFATEGENTAMICIN SULFATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-207Gentamicin SulfateGentamicin SulfateGeneral Injectables & Vaccines, IncANDACurrent
52584-207Gentamicin SulfateGentamicin SulfateGeneral Injectables & Vaccines, IncANDACurrent
52584-207Gentamicin SulfateGentamicin SulfateGeneral Injectables & Vaccines, IncANDACurrent
55154-2392Gentamicin SulfateGentamicin SulfateCardinal HealthANDACurrent
55154-2392Gentamicin SulfateGentamicin SulfateCardinal Health 107, LLCANDACurrent
55154-2392Gentamicin SulfateGentamicin SulfateCardinal HealthANDACurrent
55154-2392Gentamicin SulfateGentamicin SulfateCardinal HealthANDACurrent
71872-7216Gentamicin SulfateGENTAMICIN SULFATEMedical Purchasing Solutions, LLCANDACurrent