Home NDC 0078-0670 VOTRIENT
Product NDC 0078-0670
11-digit product format 000780670
Labeler code 0078
Product ID 0078-0670_d64a4078-2cff-48a7-a621-c31d82703ae6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pazopanib hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA022465
Marketing category NDA
Marketing start 2016-07-12
Marketing end 0000-00-00
Substance PAZOPANIB HYDROCHLORIDE
Active strength 200 mg/1
Pharmacologic classes Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0078-0670-66 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0078-0670-66 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0078-0670-66 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0078-0670-66 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0078-0670-66 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0078-0670-66 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0078-0670-66 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0078-0670-66 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0078-0670-66 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0078-0670-66 ad56d346431e…cc804d4bbf1e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022465-001 VOTRIENT PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 N022465-002 VOTRIENT PAZOPANIB HYDROCHLORIDE EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022465-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL RLD, RS 2009-10-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL RLD, RS 2009-10-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022465-002 VOTRIENT EQ 400MG BASE TABLET / ORAL RLD 2009-10-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL RLD, RS 2009-10-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022465-002 VOTRIENT EQ 400MG BASE TABLET / ORAL RLD 2009-10-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL RLD, RS 2009-10-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022465-002 VOTRIENT EQ 400MG BASE TABLET / ORAL 2009-10-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL RLD, RS 2009-10-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 bb7c543d1eb4…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022465-001 7105530 2023-10-19 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022465-002 7105530 2023-10-19 Drug substance, Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022465-001 7105530 2023-10-19 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022465-002 7105530 2023-10-19 Drug substance, Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022465-001 7105530 2023-10-19 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022465-002 7105530 2023-10-19 Drug substance, Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022465-001 7262203 2021-12-19 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022465-001 8114885 2021-12-19 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022465-001 7105530 2023-10-19 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022465-002 7262203 2021-12-19 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022465-002 8114885 2021-12-19 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022465-002 7105530 2023-10-19 Drug substance, Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022465-001 7105530 2023-10-19 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022465-002 7105530 2023-10-19 Drug substance, Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022465-001 7262203 2021-12-19 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022465-001 8114885 2021-12-19 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022465-001 7105530 2023-10-19 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022465-002 7262203 2021-12-19 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022465-002 8114885 2021-12-19 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022465-002 7105530 2023-10-19 Drug substance, Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022465-001 7262203 2021-12-19 Drug substance, Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022465-001 8114885 2021-12-19 Drug substance, Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022465-001 7105530 2023-10-19 Drug substance, Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022465-002 7262203 2021-12-19 Drug substance, Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022465-002 8114885 2021-12-19 Drug substance, Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022465-002 7105530 2023-10-19 Drug substance, Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022465-001 7262203 2021-12-19 Drug substance, Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022465-001 8114885 2021-12-19 Drug substance, Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022465-001 7105530 2023-10-19 Drug substance, Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022465-002 7262203 2021-12-19 Drug substance, Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022465-002 8114885 2021-12-19 Drug substance, Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022465-002 7105530 2023-10-19 Drug substance, Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022465-001 7262203 2021-12-19 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022465-001 8114885 2021-12-19 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022465-001 7105530 2023-10-19 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022465-002 7262203 2021-12-19 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022465-002 8114885 2021-12-19 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022465-002 7105530 2023-10-19 Drug substance, Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022465-001 7262203 2021-12-19 Drug substance, Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022465-001 8114885 2021-12-19 Drug substance, Drug product c0c555d07b60…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VOTRIENT PAZOPANIB HYDROCHLORIDE Novartis Pharmaceuticals Corporation eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7 2025-12-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022465 application number: NDA022465
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0078-0670-66 00078067066 120 TABLET, FILM COATED in 1 BOTTLE (0078-0670-66) 2016-07-12 0000-00-00 No No Current