FDA.reportPublic FDA data

Application 208446

Type
ANDA
Sponsor
MYLAN

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
0378-6920Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6920Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6920Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6920Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6920Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6920Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6920Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6921Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6921Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6921Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6921Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6924Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6924Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6924Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6924Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6924Abiraterone Acetateabiraterone acetateMylan Pharmaceuticals Inc.ANDACurrent
42292-057Abiraterone Acetateabiraterone acetateMylan Institutional Inc.ANDACurrent
42292-057Abiraterone Acetateabiraterone acetateMylan Institutional Inc.ANDACurrent
51407-181Abiraterone Acetateabiraterone acetateGolden State Medical Supply Inc.ANDACurrent
51407-181Abiraterone Acetateabiraterone acetateGolden State Medical Supply, Inc.ANDACurrent
51407-181Abiraterone Acetateabiraterone acetateGolden State Medical Supply, Inc.ANDACurrent
51407-181Abiraterone Acetateabiraterone acetateGolden State Medical Supply, Inc.ANDACurrent
51407-181Abiraterone Acetateabiraterone acetateGolden State Medical Supply, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56234ORIG2018-11-01