Active ingredient
Fludarabine
6 finished FDA listings contain Fludarabine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FLUDARABINE, FLUDARABINE PHOSPHATE
- Dosage forms
- Injection, Injection, Powder, Lyophilized, For Solution, Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 6
- Strengths listed
- 25 mg/ml · 50 mg/2ml
- Brand names in FDA listings
- Fludarabine
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 24698
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 076661 | SAGENT PHARMS INC | 2004-04-28 | 1 |
| ANDA 078393 | FRESENIUS KABI USA | 2007-10-15 | 1 |
| ANDA 078610 | ACTAVIS TOTOWA | 2009-02-11 | 1 |
| ANDA 090724 | AREVA PHARMS | 2010-09-27 | 2 |
| ANDA 220196 | HISUN PHARM HANGZHOU | 2026-07-23 | 1 |
Official labeling on DailyMed
- FLUDARABINE (FLUDARABINE PHOSPHATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 5 · 2024-10-21
- FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] · version 12 · 2024-04-03
- FLUDARABINE PHOSPHATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] · version 2 · 2023-06-20
- FLUDARABINE PHOSPHATE INJECTION [LANNETT COMPANY, INC.] · version 1 · 2023-04-04
- FLUDARABINE PHOSPHATE INJECTION [AREVA PHARMACEUTICALS] · version 5 · 2023-02-16
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.