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 44.

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 2 of 2 · 44 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
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201023-001	JEVTANA KIT	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-06-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N201023-001	JEVTANA KIT	60MG/1.5ML (40MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-06-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N201023-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N201023-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201023-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201023-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201023-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201023-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201023-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201023-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201023-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201023-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201023-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201023-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201023-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201023-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201023-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201023-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201023-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201023-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201023-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201023-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201023-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201023-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201023-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201023-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201023-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201023-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201023-001	AP	1	`3a93d1ddd44b…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201023-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N201023-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 295 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N201023-001	7241907	2025-12-10		Drug substance		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201023-001	7241907*PED	2026-06-10		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201023-001	10583110	2030-10-27	U-2753		2020-03-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201023-001	10716777	2030-10-27	U-2856		2020-07-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201023-001	12453712	2030-10-27	U-4334		2025-11-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201023-001	8927592	2030-10-27	U-3200		2015-01-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201023-001	10583110*PED	2031-04-27		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201023-001	10716777*PED	2031-04-27		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201023-001	12453712*PED	2031-04-27		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201023-001	8927592*PED	2031-04-27		Pediatric extension		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N201023-001	7241907	2025-12-10		Drug substance		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201023-001	7241907*PED	2026-06-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201023-001	10583110	2030-10-27	U-2753		2020-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201023-001	10716777	2030-10-27	U-2856		2020-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201023-001	12453712	2030-10-27	U-4334		2025-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201023-001	8927592	2030-10-27	U-3200		2015-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201023-001	10583110*PED	2031-04-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201023-001	10716777*PED	2031-04-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201023-001	12453712*PED	2031-04-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201023-001	8927592*PED	2031-04-27		Pediatric extension		`84e616aacf4f…`
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…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201023-001	M-128	2023-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201023-001	M-128	2023-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201023-001	M-128	2023-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201023-001	M-201	2020-05-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201023-001	M-209	2020-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201023-001	PED	2020-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201023-001	M-128	2023-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201023-001	M-128	2023-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201023-001	M-128	2023-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201023-001	M-128	2023-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201023-001	M-201	2020-05-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201023-001	M-209	2020-09-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201023-001	PED	2020-11-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201023-001	M-201	2020-05-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N201023-001	M-209	2020-09-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N201023-001	PED	2020-11-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201023-001	M-201	2020-05-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N201023-001	M-209	2020-09-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N201023-001	PED	2020-11-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201023-001	M-201	2020-05-17	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N201023-001	M-209	2020-09-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N201023-001	PED	2020-11-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201023-001	M-201	2020-05-17	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N201023-001	M-209	2020-09-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N201023-001	PED	2020-11-17	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N201023-001	M-128	2023-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201023-001	M-128	2023-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201023-001	M-128	2023-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201023-001	M-128	2023-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201023-001	M-128	2023-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201023-001	M-128	2023-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201023-001	M-128	2023-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201023-001	M-128	2023-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201023-001	M-128	2023-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201023-001	M-128	2023-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201023-001	M-128	2023-12-18	`cb3db0bc1861…`

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74720	SUPPL	2023-07-11
74714	SUPPL	2023-07-10
66303	SUPPL	2021-02-19
66243	SUPPL	2021-02-17
65692	SUPPL	2020-12-22
65675	SUPPL	2020-12-22
62068	SUPPL	2020-03-06
51035	SUPPL	2018-01-11
51020	SUPPL	2018-01-10
49791	SUPPL	2017-09-19
49736	SUPPL	2017-09-14
48453	SUPPL	2017-05-19
48447	SUPPL	2017-05-18
45364	SUPPL	2016-09-15
45325	SUPPL	2016-09-15
32079	SUPPL	2015-06-22
18989	SUPPL	2015-06-19
51273	SUPPL	2015-03-03
32078	SUPPL	2014-11-21
40049	SUPPL	2014-11-20
51272	SUPPL	2013-05-08
32077	SUPPL	2013-04-30
9856	SUPPL	2012-10-09
18988	SUPPL	2012-10-05
51271	SUPPL	2012-03-20
44829	ORIG	2010-07-30
22842	ORIG	2010-07-30
9855	ORIG	2010-06-21
18987	ORIG	2010-06-17
52072	SUPPL	1900-01-01