FDA.reportPublic FDA data

Application 200582

Type
NDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPOTECAN HYDROCHLORIDETOPOTECAN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 4MG BASE/4ML (EQ 1MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-0302TopotecanTOPOTECANHospira, Inc.NDACurrent
0409-0302TopotecanTOPOTECANHospira, Inc.NDACurrent
0409-0302TopotecanTOPOTECANHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61339SUPPL2019-12-19
61325SUPPL2019-12-17
18966SUPPL2016-02-25
32036SUPPL2016-01-29
9830SUPPL2014-03-05
40028SUPPL2014-03-04
43348ORIG2011-05-13
24385ORIG2011-05-13
32035ORIG2011-02-07
18965ORIG2011-02-04