Application 021759

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELOXATIN	OXALIPLATIN	INJECTABLE;INTRAVENOUS	50MG/10ML (5MG/ML)	Yes	Yes
002	ELOXATIN	OXALIPLATIN	INJECTABLE;INTRAVENOUS	100MG/20ML (5MG/ML)	Yes	Yes
003	ELOXATIN	OXALIPLATIN	INJECTABLE;INTRAVENOUS	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021759-001	ELOXATIN	OXALIPLATIN	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31
N021759-002	ELOXATIN	OXALIPLATIN	100MG/20ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31
N021759-003	ELOXATIN	OXALIPLATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021759-001	ELOXATIN	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021759-002	ELOXATIN	100MG/20ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021759-001	ELOXATIN	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021759-002	ELOXATIN	100MG/20ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021759-001	ELOXATIN	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021759-002	ELOXATIN	100MG/20ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021759-001	ELOXATIN	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021759-002	ELOXATIN	100MG/20ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021759-001	ELOXATIN	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021759-002	ELOXATIN	100MG/20ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021759-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021759-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021759-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021759-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021759-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021759-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021759-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021759-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021759-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021759-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021759-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021759-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021759-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021759-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021759-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021759-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021759-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021759-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021759-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021759-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021759-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021759-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021759-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021759-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021759-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021759-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021759-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021759-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021759-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021759-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021759-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021759-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021759-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021759-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021759-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021759-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021759-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021759-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021759-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021759-002	AP	1	`9b2671bbb829…`

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxaliplatin	OXALIPLATIN	Baxter Healthcare Corporation	21a2bb1d-d91d-4f99-97dd-cc67fe99a090	2023-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Sandoz Inc	ab162009-6f84-4d56-ab56-5e84409ec814	2023-07-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Qilu Pharmaceutical Co., Ltd.	e9e47f3c-9acc-44f5-b0bd-d26fe9d35d64	2021-10-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Gland Pharma Limited	d6178bc6-9dae-413f-8f47-de75d576c5b8	2017-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXALIPLATIN

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0955-1725	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1725	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1725	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1727	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1727	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1727	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1731	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1731	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1731	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1733	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1733	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1733	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
12516-0592	ELOXATIN	oxaliplatin	Aventis Pharma Ltd.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74628	SUPPL	2023-06-27
74623	SUPPL	2023-06-26
62518	SUPPL	2020-04-09
62469	SUPPL	2020-04-07
37595	SUPPL	2015-10-07
6134	SUPPL	2015-10-06
6133	SUPPL	2013-07-18
16325	SUPPL	2013-07-17
28540	SUPPL	2012-10-16
16324	SUPPL	2012-10-15
28539	SUPPL	2012-01-03
16323	SUPPL	2011-12-28
16322	SUPPL	2009-03-26
28538	SUPPL	2009-03-17
28537	SUPPL	2008-05-28
42302	ORIG	2007-07-02
16321	SUPPL	2006-03-14
6132	SUPPL	2006-03-14
37594	ORIG	2005-02-03
28536	ORIG	2005-02-03