FDA.reportPublic FDA data

Application 201532

Type
NDA
Sponsor
EISAI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HALAVENERIBULIN MESYLATESOLUTION;INTRAVENOUS1MG/2ML (0.5MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43624-002Halaveneribulin mesylateBSP Pharmaceuticals SpANDACurrent
43624-002Halaveneribulin mesylateBSP Pharmaceuticals SpANDACurrent
43624-002Halaveneribulin mesylateBSP Pharmaceuticals SpANDACurrent
43624-002Halaveneribulin mesylateBSP Pharmaceuticals SpANDACurrent
62856-389Halaveneribulin mesylateEisai Inc.NDACurrent
62856-389Halaveneribulin mesylateEisai Inc.NDACurrent
62856-389Halaveneribulin mesylateEisai Inc.NDACurrent
62856-389Halaveneribulin mesylateEisai Inc.NDACurrent
62856-389Halaveneribulin mesylateEisai Inc.NDACurrent
62856-389Halaveneribulin mesylateEisai Inc.NDACurrent
62856-389Halaveneribulin mesylateEisai Inc.NDACurrent
62856-389Halaveneribulin mesylateEisai Inc.NDACurrent
62856-389Halaveneribulin mesylateEisai Inc.NDACurrent
62856-389Halaveneribulin mesylateEisai Inc.NDACurrent
62856-389Halaveneribulin mesylateEisai Inc.NDACurrent
62856-389Halaveneribulin mesylateEisai Inc.NDACurrent
62856-389Halaveneribulin mesylateEisai Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72078SUPPL2022-09-14
72076SUPPL2022-09-14
69812SUPPL2022-01-05
68829SUPPL2021-10-01
66320SUPPL2021-02-23
45685SUPPL2016-10-27
45573SUPPL2016-10-20
9908SUPPL2016-01-29
19025SUPPL2016-01-28
19024SUPPL2015-11-04
9907SUPPL2015-10-28
40075SUPPL2015-01-09
9906SUPPL2014-12-24
40074SUPPL2014-08-04
9905SUPPL2014-08-04
40073SUPPL2013-08-27
9904SUPPL2013-08-23
32116SUPPL2012-02-23
40072SUPPL2012-02-22
24396ORIG2011-02-17
22853ORIG2011-01-03
9903ORIG2010-11-18
40071ORIG2010-11-15