Application 202379

Type
NDA
Sponsor
JANSSEN BIOTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYTIGAABIRATERONE ACETATETABLET;ORAL250MGYesNo
002ZYTIGAABIRATERONE ACETATETABLET;ORAL500MGYesYes

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
N202379-001ZYTIGAABIRATERONE ACETATE250MGTABLET / ORALABRLD2011-04-28
N202379-002ZYTIGAABIRATERONE ACETATE500MGTABLET / ORALABRLD, RS2017-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N202379-001AB
N202379-002AB

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202379-002ZYTIGA500MGTABLET / ORALRLD, RS2017-04-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-28782e0a99824c…
2021-12-28 21:50 UTC2021-12N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-14782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N202379-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202379-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202379-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202379-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N202379-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202379-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202379-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202379-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202379-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202379-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202379-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202379-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202379-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202379-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202379-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202379-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202379-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202379-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202379-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N202379-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202379-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202379-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202379-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202379-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202379-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202379-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202379-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N202379-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202379-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202379-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202379-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N202379-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202379-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N202379-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202379-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N202379-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N202379-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N202379-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N202379-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202379-001AB187673890dc5c…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N202379-00288224382027-08-24U-2235Delist requested2017-08-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202379-00288224382027-08-24U-1580Delist requested2017-08-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202379-00288224382027-08-24U-1579Delist requested2017-08-0274a2ff9319b5…
2020-12-22 03:56 UTC2020-12N202379-00288224382027-08-24U-2235Delist requested2017-08-028869cabd3fbd…
2020-12-22 03:56 UTC2020-12N202379-00288224382027-08-24U-1580Delist requested2017-08-028869cabd3fbd…
2020-12-22 03:56 UTC2020-12N202379-00288224382027-08-24U-1579Delist requested2017-08-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202379-00288224382027-08-24U-2235Delist requested2017-08-02c0c555d07b60…
2020-11-12 02:37 UTC2020-11N202379-00288224382027-08-24U-1580Delist requested2017-08-02c0c555d07b60…
2020-11-12 02:37 UTC2020-11N202379-00288224382027-08-24U-1579Delist requested2017-08-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202379-00288224382027-08-24U-2235Delist requested2017-08-023f01610625f2…
2019-12-14 00:12 UTC2019-12N202379-00288224382027-08-24U-1580Delist requested2017-08-023f01610625f2…
2019-12-14 00:12 UTC2019-12N202379-00288224382027-08-24U-1579Delist requested2017-08-023f01610625f2…
2019-09-15 20:21 UTC2019-09N202379-00188224382027-08-24U-15802014-10-01b00525d2431f…
2019-09-15 20:21 UTC2019-09N202379-00188224382027-08-24U-22352014-10-01b00525d2431f…
2019-09-15 20:21 UTC2019-09N202379-00188224382027-08-24U-15792014-10-01b00525d2431f…
2019-09-15 20:21 UTC2019-09N202379-00288224382027-08-24U-22352017-08-02b00525d2431f…
2019-09-15 20:21 UTC2019-09N202379-00288224382027-08-24U-15802017-08-02b00525d2431f…
2019-09-15 20:21 UTC2019-09N202379-00288224382027-08-24U-15792017-08-02b00525d2431f…
2019-07-19 19:46 UTC2019-07N202379-00188224382027-08-24U-15792014-10-01ea99ee380514…
2019-07-19 19:46 UTC2019-07N202379-00188224382027-08-24U-15802014-10-01ea99ee380514…
2019-07-19 19:46 UTC2019-07N202379-00188224382027-08-24U-22352014-10-01ea99ee380514…
2019-07-19 19:46 UTC2019-07N202379-00288224382027-08-24U-22352017-08-02ea99ee380514…
2019-07-19 19:46 UTC2019-07N202379-00288224382027-08-24U-15802017-08-02ea99ee380514…
2019-07-19 19:46 UTC2019-07N202379-00288224382027-08-24U-15792017-08-02ea99ee380514…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N202379-001I-7652021-02-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202379-002I-7652021-02-0774a2ff9319b5…
2021-12-28 21:50 UTC2021-12N202379-001I-7652021-02-07782e0a99824c…
2021-12-28 21:50 UTC2021-12N202379-002I-7652021-02-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202379-001I-7652021-02-0787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202379-002I-7652021-02-0787673890dc5c…
2021-03-12 10:30 UTC2021-03N202379-001I-7652021-02-075aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N202379-002I-7652021-02-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N202379-001I-7652021-02-078869cabd3fbd…
2020-12-22 03:56 UTC2020-12N202379-002I-7652021-02-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202379-001I-7652021-02-07c0c555d07b60…
2020-11-12 02:37 UTC2020-11N202379-002I-7652021-02-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202379-001I-7652021-02-073f01610625f2…
2019-12-14 00:12 UTC2019-12N202379-002I-7652021-02-073f01610625f2…
2019-09-15 20:21 UTC2019-09N202379-001I-7652021-02-07b00525d2431f…
2019-09-15 20:21 UTC2019-09N202379-002I-7652021-02-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N202379-001I-7652021-02-07ea99ee380514…
2019-07-19 19:46 UTC2019-07N202379-002I-7652021-02-07ea99ee380514…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZytigaABIRATERONE ACETATEJanssen Biotech, Inc.4e338e89-3cf2-48eb-b6e2-a06c608c65132025-03-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 202379
application number: NDA202379
ndc (product): 57894-195
ndc (product): 57894-150

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
57894-150Zytigaabiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-150Zytigaabiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-150Zytigaabiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-150Zytigaabiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-150Zytigaabiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-150Zytigaabiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-150Zytigaabiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-155Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDA AUTHORIZED GENERICCurrent
57894-155Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDA AUTHORIZED GENERICCurrent
57894-155Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDA AUTHORIZED GENERICCurrent
57894-155Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDA AUTHORIZED GENERICCurrent
57894-155Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDA AUTHORIZED GENERICCurrent
57894-155Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDA AUTHORIZED GENERICCurrent
57894-195ZytigaAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-195ZytigaAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-195ZytigaAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-195ZytigaAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-195ZytigaAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-195ZytigaAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-195ZytigaAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-199Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-199Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDACurrent
57894-199Abiraterone acetateAbiraterone acetateJanssen Biotech, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68458SUPPL2021-08-25
68455SUPPL2021-08-25
64851SUPPL2020-10-06
64850SUPPL2020-10-06
64826SUPPL2020-10-05
64825SUPPL2020-10-05
58979SUPPL2019-06-05
58978SUPPL2019-06-05
58973SUPPL2019-06-05
58972SUPPL2019-06-05
55746SUPPL2018-10-01
55617SUPPL2018-09-26
54304SUPPL2018-05-22
52563SUPPL2018-02-12
52522SUPPL2018-02-08
45794SUPPL2016-11-02
40178SUPPL2016-05-20
32253SUPPL2016-05-19
19342SUPPL2015-12-15
32252SUPPL2015-12-11
19341SUPPL2015-05-27
10041SUPPL2015-05-22
32251SUPPL2015-03-24
19340SUPPL2015-03-24
40177SUPPL2015-01-29
10040SUPPL2015-01-26
10039SUPPL2014-05-19
19339SUPPL2014-05-15
22888SUPPL2014-01-16
19338SUPPL2013-09-17
10038SUPPL2013-09-13
19337SUPPL2012-12-14
10037SUPPL2012-12-12
32250SUPPL2012-09-20
40176SUPPL2012-09-17
40175SUPPL2012-07-13
10036SUPPL2012-07-09
44856ORIG2011-05-27
43400ORIG2011-05-27
32249ORIG2011-05-03
19336ORIG2011-04-28