FDA.reportPublic FDA data

Application 208432

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABIRATERONE ACETATEABIRATERONE ACETATETABLET;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-1125Abiraterone AcetateAbiraterone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1125Abiraterone AcetateAbiraterone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1125Abiraterone AcetateAbiraterone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1125Abiraterone AcetateAbiraterone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1125Abiraterone AcetateAbiraterone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1125Abiraterone AcetateAbiraterone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1125Abiraterone AcetateAbiraterone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1125Abiraterone AcetateAbiraterone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56233ORIG2018-11-01