FDA.reportPublic FDA data

Application 020866

Type
NDA
Sponsor
VEROSCIENCE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOSETBROMOCRIPTINE MESYLATETABLET;ORALEQ 0.8MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68012-258CYCLOSETbromocriptine mesylateSantarus, Inc.NDACurrent
68012-258CYCLOSETbromocriptine mesylateSantarus, Inc.NDACurrent
68012-258CYCLOSETbromocriptine mesylateSantarus, Inc.NDACurrent
68012-258CYCLOSETbromocriptine mesylateSantarus, Inc.NDACurrent
68012-258CYCLOSETbromocriptine mesylateSantarus, Inc.NDACurrent
68012-258CYCLOSETbromocriptine mesylateSantarus, Inc.NDACurrent
68012-258CYCLOSETbromocriptine mesylateSantarus, Inc.NDACurrent
68012-258CYCLOSETbromocriptine mesylateSantarus, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64295SUPPL2020-08-18
64291SUPPL2020-08-18
62624SUPPL2020-04-22
62450SUPPL2020-04-06
47123SUPPL2017-02-07
47122SUPPL2017-02-07
47121SUPPL2017-02-07
47120SUPPL2017-02-07
13645SUPPL2016-02-11
3616SUPPL2016-02-04
13644SUPPL2015-10-22
3615SUPPL2015-10-21
24182ORIG2011-10-03
21032ORIG2011-10-03
35535SUPPL2011-03-28
3614SUPPL2011-03-28