FDA.reportPublic FDA data

Application 209227

Type
ANDA
Sponsor
GLENMARK PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABIRATERONE ACETATEABIRATERONE ACETATETABLET;ORAL250MGNoNo
002ABIRATERONE ACETATEABIRATERONE ACETATETABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68462-135abiraterone acetateabiraterone acetateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-135abiraterone acetateabiraterone acetateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-135abiraterone acetateabiraterone acetateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-135abiraterone acetateabiraterone acetateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-135abiraterone acetateabiraterone acetateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-882abiraterone acetateabiraterone acetateGlenmark Pharmaceuticals Inc., USAANDACurrent
72603-110abiraterone acetateabiraterone acetateNORTHSTAR RX LLCANDACurrent
72603-110abiraterone acetateabiraterone acetateNORTHSTAR RX LLCANDACurrent
72603-111abiraterone acetateabiraterone acetateNORTHSTAR RX LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57749ORIG2019-02-21