FDA.reportPublic FDA data

Application 075293

Type
ANDA
Sponsor
HOSPIRA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9915MidazolamMidazolamHenry Schein, Inc.ANDACurrent
0409-2587Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2587Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2587Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2587Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2587Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2587Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2587Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2587Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2596Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2596Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2596Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2596Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2596Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2596Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2596Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2596Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2596Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2596Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2596Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2596Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHospira, Inc.ANDACurrent
50090-5342Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-5342Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-5472Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEA-S Medication SolutionsANDACurrent
52584-596MidazolamMidazolamGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-596MidazolamMidazolamGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-596MidazolamMidazolamGeneral Injectables and Vaccines, Inc.ANDACurrent
68258-8981Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEDispensing Solutions, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52645SUPPL2018-02-14
8603ORIG2004-06-09
30836ORIG2000-06-20