FDA.reportPublic FDA data

Application 017697

Type
NDA
Sponsor
BRACCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KINEVACSINCALIDEINJECTABLE;INJECTION0.005MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0270-0556KINEVACsincalideBracco Diagnostics Inc.NDACurrent
0270-0556KINEVACsincalideBracco Diagnostics Inc.NDACurrent
0270-0556KINEVACsincalideBracco Diagnostics Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75874SUPPL 2023-10-20
75835SUPPL 2023-10-18
56926SUPPL2018-12-21
56788SUPPL2018-12-19
54303SUPPL2018-05-22
54301SUPPL2018-05-22
53145SUPPL2018-03-22
53143SUPPL2018-03-22
52628SUPPL2018-02-14
52551SUPPL2018-02-09
40755SUPPL2012-11-09
20086SUPPL2012-11-09
20085SUPPL2012-11-09
20084SUPPL2012-11-09
13885SUPPL2005-04-28
13884SUPPL2004-06-07
691SUPPL2004-06-07
690SUPPL2004-06-07
689SUPPL2004-06-07