FDA.reportPublic FDA data

Application 204886

Type
NDA
Sponsor
TOPROL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZONTIVITYVORAPAXAR SULFATETABLET;ORALEQ 2.08MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66992-208ZONTIVITYvorapaxarWraSer Pharmaceuticals, LLCNDACurrent
66992-208ZONTIVITYvorapaxarWraSer Pharmaceuticals, LLCNDACurrent
70347-208ZONTIVITYvorapaxarAralez Pharmaceuticals Us Inc.NDACurrent
70347-208ZONTIVITYvorapaxarAralez Pharmaceuticals Us Inc.NDACurrent
70347-208ZONTIVITYvorapaxarAralez Pharmaceuticals Us Inc.NDACurrent
70347-208ZONTIVITYvorapaxarAralez Pharmaceuticals Us Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60833SUPPL2019-11-14
60805SUPPL2019-11-12
23518SUPPL2015-05-27
32603SUPPL2015-04-17
19609SUPPL2015-04-17
43481ORIG2014-06-18
24484ORIG2014-06-18
19608ORIG2014-05-12
10405ORIG2014-05-09