FDA.reportPublic FDA data

Application 205098

Type
NDA
Sponsor
PROVENSIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VARITHENAPOLIDOCANOLSOLUTION;INTRAVENOUS180MG/18ML (10MG/ML)YesYes
002VARITHENAPOLIDOCANOLSOLUTION;INTRAVENOUS77.5MG/7.75ML (10MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60635-107VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-107VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-107VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-107VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-111VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-111VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-111VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-111VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-118VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-118VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-118VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-118VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-118VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-123VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-133VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-133VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-133VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-133VarithenapolidocanolBiocompatibles, Inc.NDACurrent
60635-133VarithenapolidocanolBiocompatibles, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59811SUPPL2019-08-22
59801SUPPL2019-08-22
50922SUPPL2017-12-27
50921SUPPL2017-12-27
40443SUPPL2016-06-27
32629SUPPL2016-06-24
40442SUPPL2015-01-12
10425SUPPL2015-01-09
44913ORIG2014-07-28
43484ORIG2014-07-28
19623SUPPL2014-07-03
10424SUPPL2014-06-27
10423ORIG2013-11-27
40441ORIG2013-11-26