FDA.reportPublic FDA data

Application 018227

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMIDATEETOMIDATEINJECTABLE;INJECTION2MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9811AmidateEtomidateHenry Schein, Inc.NDACurrent
0409-6695AmidateETOMIDATEHospira, Inc.NDACurrent
0409-6695AmidateETOMIDATEHospira, Inc.NDACurrent
0409-6695AmidateETOMIDATEHospira, Inc.NDACurrent
0409-6695AmidateETOMIDATEHospira, Inc.NDACurrent
0409-6695AmidateETOMIDATEHospira, Inc.NDACurrent
0409-8060AmidateEtomidateHospira, Inc.NDACurrent
0409-8060AmidateEtomidateHospira, Inc.NDACurrent
51662-1455AMIDATE(TM) ETOMIDATEAMIDATE(TM) ETOMIDATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1455AMIDATE(TM) ETOMIDATEAMIDATE(TM) ETOMIDATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1459AMIDATE(TM) ETOMIDATEAMIDATE(TM) ETOMIDATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
52584-695AmidateEtomidateGeneral Injectables & Vaccines, IncNDACurrent
52584-695AmidateEtomidateGeneral Injectables & Vaccines, IncNDACurrent
52584-695AmidateEtomidateGeneral Injectables & Vaccines, IncNDACurrent
52584-695AmidateEtomidateGeneral Injectables & Vaccines, IncNDACurrent
52584-695AmidateEtomidateGeneral Injectables & Vaccines, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48219SUPPL2017-05-02
48191SUPPL2017-05-02
20116SUPPL2006-05-10