FDA.reportPublic FDA data

Application 207953

Type
NDA
Sponsor
JANSSEN PRODS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001YONDELISTRABECTEDINPOWDER;INTRAVENOUS1MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59676-610YONDELISTrabectedinJanssen Products, LPNDACurrent
59676-610YONDELISTrabectedinJanssen Products, LPNDACurrent
59676-610YONDELISTrabectedinJanssen Products, LPNDACurrent
59676-610YONDELISTrabectedinJanssen Products, LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84665SUPPL 2026-01-06
84620SUPPL 2025-12-31
63411SUPPL2020-06-04
63410SUPPL2020-06-03
57099SUPPL2019-01-02
57054SUPPL2018-12-30
54828SUPPL2018-07-06
54809SUPPL2018-07-06
54770SUPPL2018-07-05
48461SUPPL2017-05-19
48450SUPPL2017-05-19
32869SUPPL2016-07-22
40602SUPPL2016-07-21
44966ORIG2015-12-02
23044ORIG2015-12-02
32868ORIG2015-10-23
19977ORIG2015-10-23
64093ORIG1900-01-01
63285ORIG1900-01-01
63284SUPPL1900-01-01