Application 021492

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OXALIPLATIN	INJECTABLE;INTRAVENOUS	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	ELOXATIN	OXALIPLATIN	INJECTABLE;INTRAVENOUS	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 44.

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
N021492-001	ELOXATIN	OXALIPLATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2002-08-09
N021492-002	ELOXATIN	OXALIPLATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2002-08-09

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021492-002	ELOXATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021492-002	ELOXATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021492-001	ELOXATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021492-002	ELOXATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	RLD	2002-08-09	`4b0b4de00fa7…`

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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62511	SUPPL	2020-04-09
62460	SUPPL	2020-04-07
37067	SUPPL	2015-10-06
5540	SUPPL	2015-10-06
5539	SUPPL	2012-10-16
37066	SUPPL	2012-10-15
27927	SUPPL	2012-01-03
15598	SUPPL	2011-12-28
15597	SUPPL	2009-03-26
5538	SUPPL	2009-03-17
27926	SUPPL	2008-05-28
27925	SUPPL	2007-01-16
15596	SUPPL	2007-01-16
21692	SUPPL	2006-03-24
37065	SUPPL	2006-03-14
27924	SUPPL	2006-03-14
27923	SUPPL	2004-11-08
5537	SUPPL	2004-11-08
37064	SUPPL	2004-11-05
15595	SUPPL	2004-11-05
5535	SUPPL	2004-06-03
15594	SUPPL	2004-01-15
5536	SUPPL	2004-01-12
44129	ORIG	2003-04-22
37063	ORIG	2002-08-09
21691	ORIG	2002-08-09
5534	ORIG	2002-08-09
52153	SUPPL	1900-01-01
52152	SUPPL	1900-01-01
52151	SUPPL	1900-01-01
52150	SUPPL	1900-01-01
52149	SUPPL	1900-01-01