FDA.reportPublic FDA data

Application 201023

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JEVTANA KITCABAZITAXELSOLUTION;INTRAVENOUS60MG/1.5ML (40MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5824JevtanacabazitaxelSanofi-Aventis U.S. LLCNDACurrent
0024-5824JevtanacabazitaxelSanofi-Aventis U.S. LLCNDACurrent
0024-5824JevtanacabazitaxelSanofi-Aventis U.S. LLCNDACurrent
0024-5824JevtanacabazitaxelSanofi-Aventis U.S. LLCNDACurrent
0024-5824JevtanacabazitaxelSanofi-Aventis U.S. LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74720SUPPL 2023-07-11
74714SUPPL 2023-07-10
66303SUPPL2021-02-19
66243SUPPL2021-02-17
65692SUPPL2020-12-22
65675SUPPL2020-12-22
62068SUPPL2020-03-06
51035SUPPL2018-01-11
51020SUPPL2018-01-10
49791SUPPL2017-09-19
49736SUPPL2017-09-14
48453SUPPL2017-05-19
48447SUPPL2017-05-18
45364SUPPL2016-09-15
45325SUPPL2016-09-15
32079SUPPL2015-06-22
18989SUPPL2015-06-19
51273SUPPL2015-03-03
32078SUPPL2014-11-21
40049SUPPL2014-11-20
51272SUPPL2013-05-08
32077SUPPL2013-04-30
9856SUPPL2012-10-09
18988SUPPL2012-10-05
51271SUPPL2012-03-20
44829ORIG2010-07-30
22842ORIG2010-07-30
9855ORIG2010-06-21
18987ORIG2010-06-17
52072SUPPL1900-01-01