Home Applications 202379 Application 202379
Type NDA
Sponsor JANSSEN BIOTECH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZYTIGA ABIRATERONE ACETATE TABLET;ORAL 250MG Yes No 002 ZYTIGA ABIRATERONE ACETATE TABLET;ORAL 500MG Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202379-001 ZYTIGA ABIRATERONE ACETATE 250MG TABLET / ORAL AB RLD 2011-04-28 N202379-002 ZYTIGA ABIRATERONE ACETATE 500MG TABLET / ORAL AB RLD, RS 2017-04-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202379-002 ZYTIGA 500MG TABLET / ORAL RLD, RS 2017-04-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N202379-002 8822438 2027-08-24 U-2235 Delist requested 2017-08-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202379-002 8822438 2027-08-24 U-1580 Delist requested 2017-08-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202379-002 8822438 2027-08-24 U-1579 Delist requested 2017-08-02 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N202379-002 8822438 2027-08-24 U-2235 Delist requested 2017-08-02 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202379-002 8822438 2027-08-24 U-1580 Delist requested 2017-08-02 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202379-002 8822438 2027-08-24 U-1579 Delist requested 2017-08-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202379-002 8822438 2027-08-24 U-2235 Delist requested 2017-08-02 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202379-002 8822438 2027-08-24 U-1580 Delist requested 2017-08-02 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202379-002 8822438 2027-08-24 U-1579 Delist requested 2017-08-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202379-002 8822438 2027-08-24 U-2235 Delist requested 2017-08-02 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N202379-002 8822438 2027-08-24 U-1580 Delist requested 2017-08-02 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N202379-002 8822438 2027-08-24 U-1579 Delist requested 2017-08-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202379-001 8822438 2027-08-24 U-1580 2014-10-01 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N202379-001 8822438 2027-08-24 U-2235 2014-10-01 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N202379-001 8822438 2027-08-24 U-1579 2014-10-01 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N202379-002 8822438 2027-08-24 U-2235 2017-08-02 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N202379-002 8822438 2027-08-24 U-1580 2017-08-02 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N202379-002 8822438 2027-08-24 U-1579 2017-08-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202379-001 8822438 2027-08-24 U-1579 2014-10-01 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N202379-001 8822438 2027-08-24 U-1580 2014-10-01 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N202379-001 8822438 2027-08-24 U-2235 2014-10-01 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N202379-002 8822438 2027-08-24 U-2235 2017-08-02 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N202379-002 8822438 2027-08-24 U-1580 2017-08-02 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N202379-002 8822438 2027-08-24 U-1579 2017-08-02 ea99ee380514…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 23 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 57894-150 Zytiga abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-150 Zytiga abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-150 Zytiga abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-150 Zytiga abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-150 Zytiga abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-150 Zytiga abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-150 Zytiga abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-155 Abiraterone acetate Abiraterone acetate Janssen Biotech, Inc. NDA AUTHORIZED GENERIC Current 57894-155 Abiraterone acetate Abiraterone acetate Janssen Biotech, Inc. NDA AUTHORIZED GENERIC Current 57894-155 Abiraterone acetate Abiraterone acetate Janssen Biotech, Inc. NDA AUTHORIZED GENERIC Current 57894-155 Abiraterone acetate Abiraterone acetate Janssen Biotech, Inc. NDA AUTHORIZED GENERIC Current 57894-155 Abiraterone acetate Abiraterone acetate Janssen Biotech, Inc. NDA AUTHORIZED GENERIC Current 57894-155 Abiraterone acetate Abiraterone acetate Janssen Biotech, Inc. NDA AUTHORIZED GENERIC Current 57894-195 Zytiga Abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-195 Zytiga Abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-195 Zytiga Abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-195 Zytiga Abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-195 Zytiga Abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-195 Zytiga Abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-195 Zytiga Abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-199 Abiraterone acetate Abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-199 Abiraterone acetate Abiraterone acetate Janssen Biotech, Inc. NDA Current 57894-199 Abiraterone acetate Abiraterone acetate Janssen Biotech, Inc. NDA Current