Application 021492
- Type
- NDA
- Sponsor
- SANOFI AVENTIS US
Application Products#
| 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OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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OXALIPLATIN | INJECTABLE;INTRAVENOUS | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| 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N021492-001 | ELOXATIN | OXALIPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2002-08-09 | |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N021492-002 | ELOXATIN | OXALIPLATIN | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2002-08-09 |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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | 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| 2026-09 | N021492-001 | ELOXATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2002-08-09 | c2088c7a36db… | |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| 2026-09 | N021492-002 | ELOXATIN | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2002-08-09 | c2088c7a36db… | |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| 2026-08 | N021492-001 | ELOXATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2002-08-09 | 84e616aacf4f… | |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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Oxaliplatin | OXALIPLATIN | Gland Pharma Limited | a6f89dc3-a594-4b5b-8728-272e20c1ecb5 | 2026-08-24 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Hospira, Inc. | e51a62ba-d163-4c57-835c-8c86cf097e40 | 2026-08-07 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| oxaliplatin | OXALIPLATIN | Shandong New Time Pharmaceutical Co., Ltd. | 1ac38523-480b-4c0f-97a1-7dfa1432923c | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | NorthStar Rx LLC | f299b2d2-86ed-4fb8-822e-65455a0bb75a | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Northstar Rx LLC | 7dc8dfb1-dec8-43b3-b2ea-05eac054b2c6 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Camber Pharmaceuticals, Inc. | b0799e39-7b1e-430a-b159-062b39521001 | 2025-09-29 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| oxaliplatin | OXALIPLATIN | Sagent Pharmaceuticals | 29a5d098-bfa7-4a65-bb4f-5daa1fef1c2f | 2025-09-09 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Mylan Institutional LLC | da0e8523-609a-4326-96b1-d7de78662d91 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | BluePoint Laboratories | b6083405-9b45-4d2c-e053-2995a90ad9ef | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Qilu Pharmaceutical Co., Ltd. | 33d4f4b4-bb4e-46af-9e89-df20154436d0 | 2024-11-14 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Meitheal Pharmaceuticals Inc. | 11377169-7986-45b1-8298-6f0533efa3c3 | 2024-10-03 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Meitheal Pharmaceuticals Inc. | ee2e0da9-5ae7-405b-8dd1-635be72bc439 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Apotex Corp. | ee5a5a1d-63f6-4d5a-901b-65be45ec6610 | 2024-08-04 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Apotex Corp. | bb180ec5-1f75-43c1-9f63-c0657af2ca5f | 2024-08-04 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Eugia US LLC | 1bb4febd-0ed4-48c9-ba2a-e22183a2143f | 2024-07-02 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Meitheal Pharmaceuticals Inc. | 7e38318e-c569-4ad4-8f10-a235f30444d1 | 2024-06-25 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Meitheal Pharmaceuticals Inc. | 873fa936-157a-4f85-bc70-5df31d71d122 | 2024-06-24 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| oxaliplatin | OXALIPLATIN | Accord Healthcare Inc. | 4b805925-beb1-2bac-e054-00144ff88e88 | 2024-01-05 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | FOSUN PHARMA USA INC. | fad0f147-6595-4412-87a7-2afca0192a96 | 2023-10-09 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Sandoz Inc | 86f6c19d-30d1-42e3-8d46-5e3f45776e85 | 2023-07-25 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| 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 |