Application 022465

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VOTRIENTPAZOPANIB HYDROCHLORIDETABLET;ORALEQ 200MG BASEYesYes
002VOTRIENTPAZOPANIB HYDROCHLORIDETABLET;ORALEQ 400MG BASEYesNo

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

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
N022465-001VOTRIENTPAZOPANIB HYDROCHLORIDEEQ 200MG BASETABLET / ORALABRLD, RS2009-10-19
N022465-002VOTRIENTPAZOPANIB HYDROCHLORIDEEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022465-001AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022465-001VOTRIENTEQ 200MG BASETABLET / ORALRLD, RS2009-10-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022465-001VOTRIENTEQ 200MG BASETABLET / ORALRLD, RS2009-10-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022465-002VOTRIENTEQ 400MG BASETABLET / ORALRLD2009-10-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022465-001VOTRIENTEQ 200MG BASETABLET / ORALRLD, RS2009-10-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022465-002VOTRIENTEQ 400MG BASETABLET / ORALRLD2009-10-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022465-001VOTRIENTEQ 200MG BASETABLET / ORALRLD, RS2009-10-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022465-002VOTRIENTEQ 400MG BASETABLET / ORAL2009-10-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022465-001VOTRIENTEQ 200MG BASETABLET / ORALRLD, RS2009-10-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-19bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N022465-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022465-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022465-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022465-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022465-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022465-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022465-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022465-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022465-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022465-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022465-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022465-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022465-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022465-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022465-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022465-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022465-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022465-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022465-001AB1a72a2bbeb626…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022465-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022465-00171055302023-10-19Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022465-00271055302023-10-19Drug substance, Drug product5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022465-00171055302023-10-19Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022465-00271055302023-10-19Drug substance, Drug product5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022465-00171055302023-10-19Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022465-00271055302023-10-19Drug substance, Drug product4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022465-00172622032021-12-19Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022465-00181148852021-12-19Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022465-00171055302023-10-19Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022465-00272622032021-12-19Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022465-00281148852021-12-19Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022465-00271055302023-10-19Drug substance, Drug product74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022465-00171055302023-10-19Drug substance, Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022465-00271055302023-10-19Drug substance, Drug productbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022465-00172622032021-12-19Drug substance, Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N022465-00181148852021-12-19Drug substance, Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N022465-00171055302023-10-19Drug substance, Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N022465-00272622032021-12-19Drug substance, Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N022465-00281148852021-12-19Drug substance, Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N022465-00271055302023-10-19Drug substance, Drug product782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022465-00172622032021-12-19Drug substance, Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022465-00181148852021-12-19Drug substance, Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022465-00171055302023-10-19Drug substance, Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022465-00272622032021-12-19Drug substance, Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022465-00281148852021-12-19Drug substance, Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022465-00271055302023-10-19Drug substance, Drug product87673890dc5c…
2021-03-12 10:30 UTC2021-03N022465-00172622032021-12-19Drug substance, Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022465-00181148852021-12-19Drug substance, Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022465-00171055302023-10-19Drug substance, Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022465-00272622032021-12-19Drug substance, Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022465-00281148852021-12-19Drug substance, Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022465-00271055302023-10-19Drug substance, Drug product5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022465-00172622032021-12-19Drug substance, Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022465-00181148852021-12-19Drug substance, Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022465-00171055302023-10-19Drug substance, Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022465-00272622032021-12-19Drug substance, Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022465-00281148852021-12-19Drug substance, Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022465-00271055302023-10-19Drug substance, Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022465-00172622032021-12-19Drug substance, Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022465-00181148852021-12-19Drug substance, Drug productc0c555d07b60…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N022465-001ODE-232019-04-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022465-002ODE-232019-04-2674a2ff9319b5…
2019-12-14 00:12 UTC2019-12N022465-001ODE-232019-04-263f01610625f2…
2019-12-14 00:12 UTC2019-12N022465-002ODE-232019-04-263f01610625f2…
2019-09-15 20:21 UTC2019-09N022465-001ODE-232019-04-26b00525d2431f…
2019-09-15 20:21 UTC2019-09N022465-002ODE-232019-04-26b00525d2431f…
2019-07-19 19:46 UTC2019-07N022465-001ODE-232019-04-26ea99ee380514…
2019-07-19 19:46 UTC2019-07N022465-002ODE-232019-04-26ea99ee380514…

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
VOTRIENTPAZOPANIB HYDROCHLORIDENovartis Pharmaceuticals Corporationeeaaaf38-fb86-4d9f-a19d-0f61daac2fd72025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022465
application number: NDA022465
ndc (product): 0078-1077

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0670VOTRIENTpazopanib hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0670VOTRIENTpazopanib hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0670VOTRIENTpazopanib hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0670VOTRIENTpazopanib hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0670VOTRIENTpazopanib hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0670VOTRIENTpazopanib hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0670VOTRIENTpazopanib hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0670VOTRIENTpazopanib hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-1077VOTRIENTpazopanib hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-1077VOTRIENTpazopanib hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-1077VOTRIENTpazopanib hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77316SUPPL 2024-01-26
77313SUPPL 2024-01-26
77312SUPPL 2024-01-26
70233SUPPL2022-02-23
70185SUPPL2022-02-18
68816SUPPL2021-09-30
68815SUPPL2021-09-30
68814SUPPL2021-09-30
68733SUPPL2021-09-23
68732SUPPL2021-09-23
64294SUPPL2020-08-18
64293SUPPL2020-08-18
64292SUPPL2020-08-18
64058SUPPL2020-07-23
64057SUPPL2020-07-23
63974SUPPL2020-07-20
63467SUPPL2020-06-09
63466SUPPL2020-06-09
63408SUPPL2020-06-03
48646SUPPL2017-06-05
48645SUPPL2017-06-05
48623SUPPL2017-06-01
48622SUPPL2017-06-01
48621SUPPL2017-06-01
48620SUPPL2017-06-01
45038SUPPL2016-08-05
45002SUPPL2016-08-05
29757SUPPL2016-05-24
17615SUPPL2016-05-23
17614SUPPL2015-10-06
29756SUPPL2015-09-24
38741SUPPL2015-04-02
7431SUPPL2015-04-02
17613SUPPL2015-04-01
17612SUPPL2014-11-20
7430SUPPL2014-11-20
29755SUPPL2014-06-05
38740SUPPL2014-06-04
7429SUPPL2013-12-18
38739SUPPL2013-12-03
29754SUPPL2013-08-16
29753SUPPL2013-08-16
7428SUPPL2013-08-16
38738SUPPL2013-08-15
17611SUPPL2013-08-15
17610SUPPL2013-08-15
38737SUPPL2012-11-16
7427SUPPL2012-11-16
29752SUPPL2012-05-02
7425SUPPL2012-05-02
17609SUPPL2012-04-27
17607SUPPL2012-04-27
7426SUPPL2012-03-26
17608SUPPL2012-03-23
38736SUPPL2012-01-23
7424SUPPL2012-01-17
38735SUPPL2011-10-25
17606SUPPL2011-10-25
7422SUPPL2011-10-25
7421SUPPL2011-10-25
7423SUPPL2011-04-22
38734SUPPL2010-05-07
7420SUPPL2010-05-03
24315ORIG2010-01-22
22028ORIG2010-01-22
7419ORIG2009-11-03
17605ORIG2009-10-20