Application 209359

Type
NDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPINEPHRINE (COPACKAGED)EPINEPHRINESOLUTION;INTRAVENOUS1MG/10ML (0.1MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-4933EPINEPHRINEepinephrineHospira, Inc.NDACurrent
0409-4933EPINEPHRINEepinephrineHospira, Inc.NDACurrent
0409-4933EPINEPHRINEepinephrineHospira, Inc.NDACurrent
51662-1531EPINEPHRINEEPINEPHRINEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1531EPINEPHRINEEPINEPHRINEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
71872-7250EPINEPHRINEepinephrineMedical Purchasing Solutions, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82215SUPPL 2025-05-21
82201SUPPL 2025-05-19
72500SUPPL2022-10-31
72488SUPPL2022-10-28
69992SUPPL2022-01-28
63760ORIG2020-06-30
62772ORIG2020-04-30
60787ORIG2019-11-07