FDA.reportPublic FDA data

Application 075857

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREEMIDAZOLAM HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1MG BASE/MLNoYes
002MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREEMIDAZOLAM HYDROCHLORIDEINJECTABLE;INJECTIONEQ 5MG BASE/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9916Midazolam HydrochlorideMidazolam HydrochlorideHenry Schein, Inc.ANDACurrent
0404-9916Midazolam HydrochlorideMidazolam HydrochlorideHenry Schein, Inc.ANDACurrent
0409-2305MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2305MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2305Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2305MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2305Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2305MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2305Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2305Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2305Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2305Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2305MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2305MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2308MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2308MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2308Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2308MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2308Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2308MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2308Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2308Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2308Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2308MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2308MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2308Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
51662-1237MIDAZOLAMMIDAZOLAMHF Acquisition Co LLC, DBANDACurrent
51662-1237MIDAZOLAMMIDAZOLAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1237MIDAZOLAMMIDAZOLAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1237MIDAZOLAMMIDAZOLAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1324MIDAZOLAMMIDAZOLAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1324MIDAZOLAMMIDAZOLAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1324MIDAZOLAMMIDAZOLAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1324MIDAZOLAMMIDAZOLAMHF Acquisition Co LLC, DBANDACurrent
52584-308Midazolam HydrochlorideMidazolam HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-308Midazolam HydrochlorideMidazolam HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-308Midazolam HydrochlorideMidazolam HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-308Midazolam HydrochlorideMidazolam HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-308Midazolam HydrochlorideMidazolam HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-308Midazolam HydrochlorideMidazolam HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
55154-4743Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDECardinal HealthANDACurrent
55154-4743Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDECardinal Health 107, LLCANDACurrent
55154-4743Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDECardinal HealthANDACurrent
55154-7831MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDECardinal HealthANDACurrent
55154-7831MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDECardinal HealthANDACurrent
68258-8973Midazolam HydrochlorideMidazolam HydrochlorideDispensing Solutions, Inc.ANDACurrent