FDA.reportPublic FDA data

Application 007513

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOPHEDNOREPINEPHRINE BITARTRATEINJECTABLE;INJECTIONEQ 1MG BASE/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-1443LevophedNorepinephrine bitartrateHospira, Inc.NDACurrent
0409-1443LevophedNorepinephrine bitartrateHospira, Inc.NDACurrent
0409-1443LevophedNorepinephrine bitartrateHospira, Inc.NDACurrent
0409-1443LevophedNorepinephrine bitartrateHospira, Inc.NDACurrent
0409-3375LEVOPHEDNOREPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-3375LEVOPHEDNOREPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-3375LEVOPHEDNOREPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-3375LEVOPHEDNOREPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-3375LEVOPHEDNOREPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-3375LEVOPHEDNOREPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-3375LEVOPHEDNOREPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-3375LEVOPHEDNOREPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
51662-1315LEVOPHED(R) NOREPINEPHRINE BITARTRATELEVOPHED(R) NOREPINEPHRINE BITARTRATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1315LEVOPHED(R) NOREPINEPHRINE BITARTRATELEVOPHED(R) NOREPINEPHRINE BITARTRATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1315LEVOPHED(R) NOREPINEPHRINE BITARTRATELEVOPHED(R) NOREPINEPHRINE BITARTRATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1315LEVOPHED(R) NOREPINEPHRINE BITARTRATELEVOPHED(R) NOREPINEPHRINE BITARTRATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1315LEVOPHED(R) NOREPINEPHRINE BITARTRATELEVOPHED(R) NOREPINEPHRINE BITARTRATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1315LEVOPHED(R) NOREPINEPHRINE BITARTRATELEVOPHED(R) NOREPINEPHRINE BITARTRATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
52584-443LevophedNorepinephrine BitartrateGeneral Injectables & Vaccines, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80153SUPPL 2024-11-05
65014SUPPL2020-10-23
64985SUPPL2020-10-23
63601SUPPL2020-06-17
63584SUPPL2020-06-17
32953SUPPL2014-12-01
134SUPPL2007-10-04