FDA.reportPublic FDA data

Application 215423

Type
NDA
Sponsor
VERU INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENTADFIFINASTERIDE;TADALAFILCAPSULE;ORAL5MG;5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69681-125ENTADFIfinasteride and tadalafilVeru Inc.NDACurrent
69681-125ENTADFIfinasteride and tadalafilVeru Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71874ORIG2022-08-24
69573ORIG2021-12-15
69534ORIG2021-12-13