Home Applications 201023 Application 201023
Type NDA
Sponsor SANOFI AVENTIS US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 JEVTANA KIT CABAZITAXEL SOLUTION;INTRAVENOUS 60MG/1.5ML (40MG/ML) Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N201023-001 JEVTANA KIT CABAZITAXEL 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N201023-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N201023-001 7241907 2025-12-10 Drug substance N201023-001 7241907*PED 2026-06-10 Pediatric extension N201023-001 10583110 2030-10-27 U-2753 2020-03-17 N201023-001 10716777 2030-10-27 U-2856 2020-07-21 N201023-001 12453712 2030-10-27 U-4334 2025-11-28 N201023-001 8927592 2030-10-27 U-3200 2015-01-12 N201023-001 10583110*PED 2031-04-27 Pediatric extension N201023-001 10716777*PED 2031-04-27 Pediatric extension N201023-001 12453712*PED 2031-04-27 Pediatric extension N201023-001 8927592*PED 2031-04-27 Pediatric extension
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 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 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-06-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-06-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-06-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-06-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-06-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-06-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-06-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-06-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-06-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-06-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-06-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-06-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-06-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-06-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-06-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N201023-001 JEVTANA KIT 60MG/1.5ML (40MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-06-17 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 7 · 275 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N201023-001 7241907 2025-12-10 Drug substance caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201023-001 7241907*PED 2026-06-10 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201023-001 10583110 2030-10-27 U-2753 2020-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201023-001 10716777 2030-10-27 U-2856 2020-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201023-001 12453712 2030-10-27 U-4334 2025-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201023-001 8927592 2030-10-27 U-3200 2015-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201023-001 10583110*PED 2031-04-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201023-001 10716777*PED 2031-04-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201023-001 12453712*PED 2031-04-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201023-001 8927592*PED 2031-04-27 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N201023-001 7241907 2025-12-10 Drug substance 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201023-001 7241907*PED 2026-06-10 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201023-001 10583110 2030-10-27 U-2753 2020-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201023-001 10716777 2030-10-27 U-2856 2020-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201023-001 12453712 2030-10-27 U-4334 2025-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201023-001 8927592 2030-10-27 U-3200 2015-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201023-001 10583110*PED 2031-04-27 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201023-001 10716777*PED 2031-04-27 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201023-001 12453712*PED 2031-04-27 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201023-001 8927592*PED 2031-04-27 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201023-001 7241907 2025-12-10 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201023-001 7241907*PED 2026-06-10 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201023-001 10583110 2030-10-27 U-2753 2020-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201023-001 10716777 2030-10-27 U-2856 2020-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201023-001 12453712 2030-10-27 U-4334 2025-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201023-001 8927592 2030-10-27 U-3200 2015-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201023-001 8927592*PED 2031-04-27 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201023-001 7241907 2025-12-10 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201023-001 7241907*PED 2026-06-10 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201023-001 10583110 2030-10-27 U-2753 2020-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201023-001 10716777 2030-10-27 U-2856 2020-07-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201023-001 8927592 2030-10-27 U-3200 2015-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201023-001 8927592*PED 2031-04-27 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201023-001 7241907 2025-12-10 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201023-001 7241907*PED 2026-06-10 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201023-001 10583110 2030-10-27 U-2753 2020-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201023-001 10716777 2030-10-27 U-2856 2020-07-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201023-001 8927592 2030-10-27 U-3200 2015-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201023-001 8927592*PED 2031-04-27 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201023-001 7241907 2025-12-10 Drug substance b8a1b40f171c…
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 Jevtana CABAZITAXEL Sanofi-Aventis U.S. LLC de3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa 2025-10-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 201023 application number: NDA201023 ndc (product): 0024-5824
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0024-5824 Jevtana cabazitaxel Sanofi-Aventis U.S. LLC NDA Current 0024-5824 Jevtana cabazitaxel Sanofi-Aventis U.S. LLC NDA Current 0024-5824 Jevtana cabazitaxel Sanofi-Aventis U.S. LLC NDA Current 0024-5824 Jevtana cabazitaxel Sanofi-Aventis U.S. LLC NDA Current 0024-5824 Jevtana cabazitaxel Sanofi-Aventis U.S. LLC NDA Current