Active ingredient
Carboplatin
40 finished FDA listings contain Carboplatin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CARBOPLATIN
- Dosage forms
- Injection, Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 11
- Strengths listed
- 10 mg/ml · 150 mg/15ml · 450 mg/45ml · 50 mg/5ml · 500 mg/50ml · 600 mg/60ml · 80 mg/8ml
- Brand names in FDA listings
- Kyxata
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 40048
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 077269 | PHARMACHEMIE BV | 2004-10-14 | 8 |
| ANDA 076517 | HOSPIRA | 2004-10-14 | 4 |
| ANDA 077059 | HOSPIRA | 2004-11-23 | 1 |
| ANDA 077266 | FRESENIUS KABI USA | 2006-02-15 | 1 |
| ANDA 077861 | TEYRO LABS | 2007-01-18 | 9 |
| ANDA 205487 | EUGIA PHARMA | 2016-03-28 | 6 |
| ANDA 206775 | ACCORD HLTHCARE | 2017-02-09 | 1 |
| ANDA 207324 | GLAND | 2017-02-15 | 8 |
| NDA 219921 | AVYXA HOLDINGS | 2025-08-08 | 2 |
Official labeling on DailyMed
- CARBOPLATIN INJECTION, SOLUTION [NATCO PHARMA USA LLC] · version 1 · 2026-08-04
- CARBOPLATIN INJECTION, SOLUTION [BPI LABS LLC] · version 5 · 2025-12-29
- KYXATA (CARBOPLATIN) INJECTION [AVYXA PHARMA, LLC] · version 6 · 2025-09-11
- CARBOPLATIN INJECTION [ACCORD HEALTHCARE, INC.] · version 8 · 2025-05-26
- CARBOPLATIN INJECTION, SOLUTION [EUGIA US LLC] · version 1 · 2025-02-03
- CARBOPLATIN INJECTION, SOLUTION [EUGIA US LLC] · version 4 · 2025-01-30
- CARBOPLATIN INJECTION, SOLUTION [TEYRO LABS PRIVATE LIMITED] · version 6 · 2025-01-10
- CARBOPLATIN INJECTION, SOLUTION [HOSPIRA, INC.] · version 2 · 2024-08-26
- CARBOPLATIN INJECTION, SOLUTION [GLAND PHARMA LIMITED] · version 4 · 2024-08-09
- CARBOPLATIN INJECTION, SOLUTION [HOSPIRA, INC.] · version 16 · 2024-06-24
- CARBOPLATIN INJECTION, SOLUTION [APOTEX CORP.] · version 2 · 2024-01-08
- CARBOPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] · version 7 · 2022-12-08
Showing the 12 most recent of 14 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.