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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208446-001ABIRATERONE ACETATEABIRATERONE ACETATE250MGTABLET / ORALAB2018-10-31
A208446-002ABIRATERONE ACETATEABIRATERONE ACETATE500MGTABLET / ORALAB2020-12-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A208446-001AB
A208446-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208446-001ABIRATERONE ACETATE250MGTABLET / ORALAB2018-10-31a50c72e98297…
2026-08-01 22:54:322026-06A208446-002ABIRATERONE ACETATE500MGTABLET / ORALAB2020-12-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208446-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208446-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Abiraterone AcetateABIRATERONE ACETATEMylan Pharmaceuticals Inc.fe02db79-fa04-441f-b514-70bd74af66242026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208446
application number: ANDA208446
ndc (product): 0378-6920
ndc (product): 0378-6921
Abiraterone AcetateABIRATERONE ACETATEBryant Ranch Prepack79082b18-adde-4ffb-832a-b8c1d030c4132023-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208446
application number: ANDA208446

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

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