FDA.reportPublic FDA data

Application 209570

Type
NDA
Sponsor
CHEMO RESEARCH SL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZNIDAZOLEBENZNIDAZOLETABLET;ORAL12.5MGYesNo
002BENZNIDAZOLEBENZNIDAZOLETABLET;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0642-7463BenznidazolebenznidazoleExeltis USA, Inc.NDACurrent
0642-7463BenznidazolebenznidazoleExeltis USA, Inc.NDACurrent
0642-7463BenznidazolebenznidazoleExeltis USA, Inc.NDACurrent
0642-7463BenznidazolebenznidazoleExeltis USA, Inc.NDACurrent
0642-7463BenznidazolebenznidazoleExeltis USA, Inc.NDACurrent
0642-7463BenznidazolebenznidazoleExeltis USA, Inc.NDACurrent
0642-7464BenznidazolebenznidazoleExeltis USA, Inc.NDACurrent
0642-7464BenznidazolebenznidazoleExeltis USA, Inc.NDACurrent
0642-7464BenznidazolebenznidazoleExeltis USA, Inc.NDACurrent
0642-7464BenznidazolebenznidazoleExeltis USA, Inc.NDACurrent
0642-7464BenznidazolebenznidazoleExeltis USA, Inc.NDACurrent
0642-7464BenznidazolebenznidazoleExeltis USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69704SUPPL2021-12-21
69613SUPPL2021-12-17
60804SUPPL2019-11-12
49990ORIG2017-10-10
49610ORIG2017-08-30
49609ORIG2017-08-30