FDA.reportPublic FDA data

Application 022453

Type
NDA
Sponsor
TEVA PHARMS USA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-4714TopotecanTopotecanTeva Parenteral Medicines, Inc.NDACurrent
0703-4714TopotecanTopotecanTeva Parenteral Medicines, Inc.NDACurrent
25021-236topotecantopotecanSagent PharmaceuticalsNDACurrent
25021-236topotecantopotecanSagent PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59181SUPPL2019-06-27
59166SUPPL2019-06-25
49838SUPPL2017-09-22
49817SUPPL2017-09-21
17596SUPPL2016-02-25
29737SUPPL2016-01-29
7406SUPPL2014-03-05
38720SUPPL2014-03-04
44755ORIG2013-07-26
22023ORIG2013-07-26
7405ORIG2012-12-26
38719ORIG2012-12-21