Application 022059

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TYKERBLAPATINIB DITOSYLATETABLET;ORALEQ 250MG BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022059-001TYKERBLAPATINIB DITOSYLATEEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022059-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022059-00188219272029-09-18Drug substance, Drug product2014-10-03

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022059-001TYKERBEQ 250MG BASETABLET / ORALRLD, RS2007-03-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-1387673890dc5c…
2021-03-12 10:30 UTC2021-03N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022059-001TYKERBEQ 250MG BASETABLET / ORALRLD, RS2007-03-133f01610625f2…
2019-09-15 20:21 UTC2019-09N022059-001TYKERBEQ 250MG BASETABLET / ORALRLD, RS2007-03-13b00525d2431f…
2019-07-19 19:46 UTC2019-07N022059-001TYKERBEQ 250MG BASETABLET / ORALRLD, RS2007-03-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-133f0d92c62455…
2023-05-13 08:27 UTC2023-05N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13053a50430f4f…
2023-01-26 05:58 UTC2023-01N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022059-001TYKERBEQ 250MG BASETABLET / ORALABRLD, RS2007-03-13e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N022059-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022059-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022059-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022059-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022059-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022059-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022059-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022059-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022059-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022059-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022059-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022059-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022059-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022059-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022059-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022059-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022059-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022059-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N022059-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022059-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022059-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N022059-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022059-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022059-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022059-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022059-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022059-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022059-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022059-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022059-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022059-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N022059-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N022059-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022059-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022059-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022059-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022059-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022059-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N022059-00188219272029-09-18Drug substance, Drug product2014-10-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022059-00188219272029-09-18Drug substance, Drug product2014-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022059-00188219272029-09-18Drug substance, Drug product2014-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N022059-00188219272029-09-18Drug substance, Drug product2014-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022059-00188219272029-09-18Drug substance, Drug product2014-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022059-00188219272029-09-18Drug substance, Drug product2014-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022059-00188219272029-09-18Drug substance, Drug product2014-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022059-00188219272029-09-18Drug substance, Drug product2014-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022059-00188219272029-09-18Drug substance, Drug product2014-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022059-00188219272029-09-18Drug substance, Drug product2014-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022059-00188219272029-09-18Drug substance, Drug product2014-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022059-00188219272029-09-18Drug substance, Drug product2014-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022059-00188219272029-09-18Drug substance, Drug product2014-10-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022059-00188219272029-09-18Drug substance, Drug product2014-10-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022059-00188219272029-09-18Drug substance, Drug product2014-10-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022059-00188219272029-09-18Drug substance, Drug product2014-10-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022059-00188219272029-09-18Drug substance, Drug product2014-10-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022059-00188219272029-09-18Drug substance, Drug product2014-10-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022059-00167272562019-01-08U-800Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022059-00167272562019-01-08U-1429Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022059-00185132622019-01-08Drug substance, Drug product2013-09-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022059-00167134852020-09-29U-800Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022059-00167134852020-09-29U-1429Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022059-00171574662021-11-19Drug substance, Drug product2013-10-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022059-00188219272029-09-18Drug substance, Drug product2014-10-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022059-00188219272029-09-18Drug substance, Drug product2014-10-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022059-00171574662021-11-19Drug substance, Drug product2013-10-24782e0a99824c…
2021-12-28 21:50 UTC2021-12N022059-00188219272029-09-18Drug substance, Drug product2014-10-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022059-00171574662021-11-19Drug substance, Drug product2013-10-2487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022059-00188219272029-09-18Drug substance, Drug product2014-10-0387673890dc5c…
2021-03-12 10:30 UTC2021-03N022059-00171574662021-11-19Drug substance, Drug product2013-10-245aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022059-00188219272029-09-18Drug substance, Drug product2014-10-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022059-00167134852020-09-29U-1429Drug substance, Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022059-00167134852020-09-29U-800Drug substance, Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022059-00171574662021-11-19Drug substance, Drug product2013-10-248869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022059-00188219272029-09-18Drug substance, Drug product2014-10-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022059-00167134852020-09-29U-800Drug substance, Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022059-00167134852020-09-29U-1429Drug substance, Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022059-00171574662021-11-19Drug substance, Drug product2013-10-24c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022059-00188219272029-09-18Drug substance, Drug product2014-10-03c0c555d07b60…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N022059-001M-2352021-12-0674a2ff9319b5…
2021-12-28 21:50 UTC2021-12N022059-001M-2352021-12-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022059-001M-2352021-12-0687673890dc5c…
2021-03-12 10:30 UTC2021-03N022059-001M-2352021-12-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022059-001M-2352021-12-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022059-001M-2352021-12-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022059-001M-2352021-12-063f01610625f2…
2019-09-15 20:21 UTC2019-09N022059-001M-2352021-12-06b00525d2431f…
2019-07-19 19:46 UTC2019-07N022059-001M-2352021-12-06ea99ee380514…

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
TYKERBLAPATINIBNovartis Pharmaceuticals Corporationeee37f88-ec6a-4c30-b8aa-e2c71f93088c2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022059
application number: NDA022059
ndc (product): 0078-0671

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0671TYKERBlapatinibNovartis Pharmaceuticals CorporationNDACurrent
0078-0671TYKERBlapatinibNovartis Pharmaceuticals CorporationNDACurrent
0078-0671TYKERBlapatinibNovartis Pharmaceuticals CorporationNDACurrent
0078-0671TYKERBlapatinibNovartis Pharmaceuticals CorporationNDACurrent
0078-0671TYKERBlapatinibNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70628SUPPL2022-03-28
70623SUPPL2022-03-28
64841SUPPL2020-10-06
60093SUPPL2019-09-24
56658SUPPL2018-12-07
56657SUPPL2018-12-07
56642SUPPL2018-12-07
56641SUPPL2018-12-07
47973SUPPL2017-04-12
47890SUPPL2017-04-05
29180SUPPL2015-04-02
38169SUPPL2015-04-01
16868SUPPL2015-01-05
29181SUPPL2014-12-30
38168SUPPL2013-10-22
38167SUPPL2013-10-22
29178SUPPL2013-10-22
29177SUPPL2013-10-22
16867SUPPL2013-06-25
16866SUPPL2013-06-25
29179SUPPL2013-06-24
29176SUPPL2013-06-24
29175SUPPL2012-02-21
38166SUPPL2012-02-17
29174SUPPL2011-08-15
29173SUPPL2011-08-15
38165SUPPL2011-08-12
16865SUPPL2011-08-12
6793SUPPL2010-03-09
6792SUPPL2010-03-09
6794SUPPL2010-02-05
38164SUPPL2010-02-01
16864SUPPL2010-02-01
16862SUPPL2010-02-01
29172SUPPL2008-07-10
16863SUPPL2008-07-09
29171SUPPL2007-08-22
38163SUPPL2007-08-21
42404ORIG2007-05-09
16861SUPPL2007-05-01
6791SUPPL2007-05-01
29170ORIG2007-03-15
38162ORIG2007-03-13