Active ingredient
Cladribine
8 finished FDA listings contain Cladribine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CLADRIBINE
- Dosage forms
- Injection, Injection, Solution, Tablet
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 7
- Strengths listed
- 1 mg/ml · 10 mg/1
- Brand names in FDA listings
- Mavenclad
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 44157
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 075405 | HIKMA | 2000-02-28 | 1 |
| ANDA 076571 | FRESENIUS KABI USA | 2004-04-22 | 1 |
| NDA 022561 | EMD SERONO INC | 2019-03-29 | 1 |
| ANDA 210856 | HISUN PHARM HANGZHOU | 2019-11-25 | 2 |
| ANDA 218425 | APOTEX | 2025-11-24 | 2 |
| ANDA 215547 | HOPEWELL PHARMA | 2026-03-27 | 1 |
Official labeling on DailyMed
- CLADRIBINE TABLET [SANDOZ INC.] · version 2 · 2026-06-22
- CLADRIBINE TABLET [APOTEX CORP.] · version 4 · 2026-06-10
- MAVENCLAD (CLADRIBINE) TABLET [EMD SERONO, INC.] · version 10 · 2026-05-29
- CLADRIBINE INJECTION, SOLUTION [HISUN PHARMACEUTICALS USA, INC.] · version 6 · 2025-12-24
- CLADRIBINE TABLET [GENVION CORPORATION] · version 2 · 2025-12-02
- CLADRIBINE INJECTION, SOLUTION [HISUN PHARMACEUTICALS USA, INC.] · version 2 · 2025-01-27
- CLADRIBINE (CLADRIBINE) INJECTION [FRESENIUS KABI USA, LLC] · version 6 · 2024-10-14
- CLADRIBINE INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 5 · 2023-04-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.