Application 202922
- Type
- ANDA
- Sponsor
- SUN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXALIPLATIN | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/10ML (5MG/ML) | No | No |
| 002 | OXALIPLATIN | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 100MG/20ML (5MG/ML) | No | No |
| 003 | OXALIPLATIN | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 200MG/40ML (5MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202922-001 | OXALIPLATIN | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | ||
| A202922-002 | OXALIPLATIN | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | ||
| A202922-003 | OXALIPLATIN | OXALIPLATIN | 200MG/40ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2019-02-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202922-001 | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202922-002 | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202922-003 | OXALIPLATIN | 200MG/40ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2019-02-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202922-001 | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202922-002 | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202922-003 | OXALIPLATIN | 200MG/40ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2019-02-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202922-001 | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202922-002 | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202922-003 | OXALIPLATIN | 200MG/40ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2019-02-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202922-001 | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202922-002 | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202922-003 | OXALIPLATIN | 200MG/40ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2019-02-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202922-001 | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202922-002 | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202922-003 | OXALIPLATIN | 200MG/40ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2019-02-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202922-001 | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202922-002 | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202922-003 | OXALIPLATIN | 200MG/40ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2019-02-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202922-001 | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202922-002 | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202922-003 | OXALIPLATIN | 200MG/40ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2019-02-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202922-001 | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202922-002 | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202922-003 | OXALIPLATIN | 200MG/40ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2019-02-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202922-001 | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202922-002 | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202922-003 | OXALIPLATIN | 200MG/40ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2019-02-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202922-001 | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202922-002 | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202922-003 | OXALIPLATIN | 200MG/40ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2019-02-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202922-001 | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202922-002 | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202922-003 | OXALIPLATIN | 200MG/40ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2019-02-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202922-001 | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202922-002 | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202922-003 | OXALIPLATIN | 200MG/40ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2019-02-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202922-001 | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202922-002 | OXALIPLATIN | 100MG/20ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202922-003 | OXALIPLATIN | 200MG/40ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2019-02-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202922-001 | OXALIPLATIN | 50MG/10ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2014-04-08 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | A202922-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A202922-002 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A202922-003 | AP | 1 | ea99ee380514… |
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 | Shandong New Time Pharmaceutical Co., Ltd. | 1ac38523-480b-4c0f-97a1-7dfa1432923c | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | oxaliplatin OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | NorthStar Rx LLC | f299b2d2-86ed-4fb8-822e-65455a0bb75a | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Northstar Rx LLC | 7dc8dfb1-dec8-43b3-b2ea-05eac054b2c6 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Camber Pharmaceuticals, Inc. | b0799e39-7b1e-430a-b159-062b39521001 | 2025-09-29 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |
| oxaliplatin | OXALIPLATIN | Sagent Pharmaceuticals | 29a5d098-bfa7-4a65-bb4f-5daa1fef1c2f | 2025-09-09 | Boxed warning, Warnings, Adverse reactions | oxaliplatin OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Mylan Institutional LLC | da0e8523-609a-4326-96b1-d7de78662d91 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | BluePoint Laboratories | b6083405-9b45-4d2c-e053-2995a90ad9ef | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Qilu Pharmaceutical Co., Ltd. | 33d4f4b4-bb4e-46af-9e89-df20154436d0 | 2024-11-14 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Meitheal Pharmaceuticals Inc. | 11377169-7986-45b1-8298-6f0533efa3c3 | 2024-10-03 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Hospira, Inc. | e51a62ba-d163-4c57-835c-8c86cf097e40 | 2024-09-25 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Meitheal Pharmaceuticals Inc. | ee2e0da9-5ae7-405b-8dd1-635be72bc439 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Apotex Corp. | ee5a5a1d-63f6-4d5a-901b-65be45ec6610 | 2024-08-04 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Apotex Corp. | bb180ec5-1f75-43c1-9f63-c0657af2ca5f | 2024-08-04 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Eugia US LLC | 1bb4febd-0ed4-48c9-ba2a-e22183a2143f | 2024-07-02 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Meitheal Pharmaceuticals Inc. | 7e38318e-c569-4ad4-8f10-a235f30444d1 | 2024-06-25 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Meitheal Pharmaceuticals Inc. | 873fa936-157a-4f85-bc70-5df31d71d122 | 2024-06-24 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |
| oxaliplatin | OXALIPLATIN | Accord Healthcare Inc. | 4b805925-beb1-2bac-e054-00144ff88e88 | 2024-01-05 | Boxed warning, Warnings, Adverse reactions | oxaliplatin OXALIPLATIN |
| OXALIPLATIN | OXALIPLATIN | Winthrop U.S, a business of sanofi-aventis U.S. LLC | 70269278-fe61-4800-a064-32cb6845cc28 | 2023-12-07 | Boxed warning, Warnings, Adverse reactions | OXALIPLATIN OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | FOSUN PHARMA USA INC. | fad0f147-6595-4412-87a7-2afca0192a96 | 2023-10-09 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |
| Oxaliplatin | OXALIPLATIN | Gland Pharma Limited | a6f89dc3-a594-4b5b-8728-272e20c1ecb5 | 2023-08-09 | Boxed warning, Warnings, Adverse reactions | Oxaliplatin OXALIPLATIN |