Active ingredient
Cisplatin
19 finished FDA listings contain Cisplatin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CISPLATIN
- Dosage forms
- Injection, Injection, Powder, Lyophilized, For Solution, Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 10
- Strengths listed
- 1 mg/ml · 100 mg/100ml · 50 mg/1 · 50 mg/50ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2555
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 |
|---|---|---|---|
| NDA 018057 | HQ SPCLT PHARMA | 1978-12-19 | 4 |
| ANDA 074735 | FRESENIUS KABI USA | 1999-07-16 | 1 |
| ANDA 074656 | PHARMACHEMIE BV | 2000-05-16 | 2 |
| ANDA 075036 | HIKMA | 2000-11-07 | 2 |
| ANDA 206774 | ACCORD HLTHCARE | 2015-08-18 | 2 |
| ANDA 207323 | GLAND | 2017-03-17 | 7 |
| ANDA 218868 | QILU | 2024-05-10 | 1 |
Official labeling on DailyMed
- CISPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WG CRITICAL CARE, LLC] · version 4 · 2026-07-06
- CISPLATIN INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 3 · 2025-11-20
- CISPLATIN INJECTION [ACCORD HEALTHCARE INC.] · version 6 · 2024-12-06
- CISPLATIN (CISPLATIN) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 7 · 2024-10-14
- CISPLATIN INJECTION, SOLUTION [APOTEX CORP.] · version 5 · 2024-09-20
- CISPLATIN INJECTION, SOLUTION [FOSUN PHARMA USA INC] · version 2 · 2024-05-20
- CISPLATIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] · version 2 · 2024-02-29
- CISPLATIN INJECTION [BLUEPOINT LABORATORIES] · version 4 · 2024-02-13
- CISPLATIN INJECTION, SOLUTION [BLUEPOINT LABORATORIES] · version 1 · 2024-01-01
- CISPLATIN INJECTION, SOLUTION [GLAND PHARMA LIMITED] · version 6 · 2023-10-18
- CISPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] · version 12 · 2022-10-03
- CISPLATIN INJECTION, SOLUTION [WG CRITICAL CARE, LLC] · version 5 · 2021-10-04
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.