Active ingredient
Clofarabine
9 finished FDA listings contain Clofarabine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CLOFARABINE
- Dosage forms
- Injection
- Routes
- Intravenous
- Manufacturers / labelers
- 9
- Strengths listed
- 1 mg/ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 44151
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 204029 | MLV | 2017-05-09 | 2 |
| ANDA 205375 | DR REDDYS | 2017-11-06 | 1 |
| ANDA 208857 | AMNEAL | 2017-11-06 | 1 |
| ANDA 209775 | MSN | 2017-12-06 | 1 |
| ANDA 207831 | GLAND | 2018-10-31 | 2 |
| ANDA 213461 | MEITHEAL | 2020-10-23 | 1 |
| ANDA 212457 | EUGIA PHARMA | 2022-10-03 | 1 |
Official labeling on DailyMed
- CLOFARABINE INJECTION [NOVADOZ PHARMACEUTICALS LLC] · version 1 · 2026-09-02
- CLOFARABINE INJECTION [FOSUN PHARMA USA INC.] · version 4 · 2025-01-10
- CLOFARABINE INJECTION [DR.REDDY'S LABORATORIES INC] · version 9 · 2024-07-01
- CLOFARABINE INJECTION [AMNEAL PHARMACEUTICALS LLC] · version 5 · 2023-12-25
- CLOFARABINE INJECTION [MEITHEAL PHARMACEUTICALS INC.] · version 4 · 2022-12-13
- CLOFARABINE INJECTION [GLAND PHARMA LIMITED] · version 6 · 2022-11-30
- CLOFARABINE INJECTION [ZYDUS LIFESCIENCES LIMITED] · version 2 · 2022-10-19
- CLOFARABINE INJECTION [EUGIA US LLC] · version 1 · 2022-10-11
- CLOFARABINE INJECTION [FRESENIUS KABI USA, LLC] · version 3 · 2020-07-15
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.