FDA.reportPublic FDA data

Application 210308

Type
NDA
Sponsor
SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001YONSAABIRATERONE ACETATETABLET;ORAL125MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-401YONSAabiraterone acetateSun Pharmaceutical Industries, Inc.NDACurrent
47335-401YONSAabiraterone acetateSun Pharmaceutical Industries, Inc.NDACurrent
47335-401YONSAabiraterone acetateSun Pharmaceutical Industries, Inc.NDACurrent
47335-401YONSAabiraterone acetateSun Pharmaceutical Industries, Inc.NDACurrent
47335-401YONSAabiraterone acetateSun Pharmaceutical Industries, Inc.NDACurrent
47335-401YONSAabiraterone acetateSun Pharmaceutical Industries, Inc.NDACurrent
47335-401YONSAabiraterone acetateSun Pharmaceutical Industries, Inc.NDACurrent
47335-401YONSAabiraterone acetateSun Pharmaceutical Industries, Inc.NDACurrent
47335-401YONSAabiraterone acetateSun Pharmaceutical Industries, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85937SUPPL 2026-05-18
85917SUPPL 2026-05-15
70607SUPPL2022-03-25
70601SUPPL2022-03-25
70040SUPPL2022-02-01
70021SUPPL2022-02-01
64614SUPPL2020-09-18
64600SUPPL2020-09-18
55868ORIG2018-10-11
54328ORIG2018-05-24
54311ORIG2018-05-23