Active ingredient
Oxaliplatin
42 finished FDA listings contain Oxaliplatin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- OXALIPLATIN
- Dosage forms
- Injection, Powder, Lyophilized, For Solution, Injection, Solution, Injection, Solution, Concentrate
- Routes
- Intravenous
- Manufacturers / labelers
- 17
- Strengths listed
- 100 mg/20ml · 200 mg/40ml · 5 mg/ml · 50 mg/10ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 32592
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 078813 | HOSPIRA WORLDWIDE | 2009-08-07 | 1 |
| ANDA 078817 | SANDOZ | 2011-01-24 | 6 |
| ANDA 091358 | MYLAN LABS LTD | 2012-08-07 | 2 |
| ANDA 203869 | HENGRUI PHARMA | 2014-06-18 | 1 |
| ANDA 204616 | QILU PHARM HAINAN | 2016-05-11 | 2 |
| ANDA 204368 | QILU PHARM HAINAN | 2016-06-07 | 6 |
| ANDA 207325 | GLAND | 2017-02-10 | 9 |
| ANDA 207474 | ACCORD HLTHCARE | 2017-03-21 | 1 |
| ANDA 207385 | GLAND | 2017-05-23 | 2 |
| ANDA 205529 | EUGIA PHARMA | 2017-09-06 | 2 |
| ANDA 217348 | MEITHEAL | 2024-01-11 | 6 |
| ANDA 217925 | HETERO LABS LTD VI | 2025-01-27 | 2 |
| ANDA 219765 | SHANDONG | 2026-01-15 | 2 |
Official labeling on DailyMed
- OXALIPLATIN INJECTION, SOLUTION [GLAND PHARMA LIMITED] · version 11 · 2026-09-01
- OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] · version 18 · 2026-08-17
- OXALIPLATIN INJECTION, SOLUTION [SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.] · version 2 · 2026-04-15
- OXALIPLATIN INJECTION, SOLUTION [NORTHSTAR RX LLC] · version 5 · 2026-01-15
- OXALIPLATIN INJECTION, SOLUTION [NORTHSTAR RX LLC] · version 7 · 2026-01-15
- OXALIPLATIN (OXALIPLATIN) INJECTION, SOLUTION, CONCENTRATE [CAMBER PHARMACEUTICALS, INC.] · version 1 · 2025-10-01
- OXALIPLATIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] · version 8 · 2025-09-22
- OXALIPLATIN INJECTION, SOLUTION [APOTEX CORP.] · version 17 · 2025-09-15
- OXALIPLATIN INJECTION, SOLUTION [APOTEX CORP.] · version 2 · 2025-09-15
- OXALIPLATIN INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 6 · 2025-09-01
- OXALIPLATIN INJECTION, SOLUTION [BLUEPOINT LABORATORIES] · version 7 · 2025-02-26
- OXALIPLATIN INJECTION, SOLUTION [FOSUN PHARMA USA INC.] · version 6 · 2025-02-05
Showing the 12 most recent of 24 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.