Active ingredient
Eribulin
17 finished FDA listings contain Eribulin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ERIBULIN, ERIBULIN MESYLATE
- Dosage forms
- Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 16
- Strengths listed
- .5 mg/ml · 1 mg/2ml
- Brand names in FDA listings
- Halaven
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1045453
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 201532 | EISAI INC | 2010-11-15 | 2 |
| ANDA 218047 | GLAND | 2024-04-05 | 3 |
| ANDA 218281 | JIANGXI KVVIT PHARM | 2024-06-28 | 1 |
| ANDA 214850 | LONG GROVE PHARMS | 2024-07-18 | 3 |
| ANDA 217250 | BAXTER HLTHCARE CORP | 2024-10-01 | 1 |
| ANDA 218743 | CHIA TAI TIANQING | 2025-03-04 | 2 |
| ANDA 214310 | SANDOZ | 2025-06-09 | 1 |
| ANDA 217473 | DR REDDYS | 2025-07-03 | 1 |
| ANDA 218142 | GLENMARK PHARMS | 2025-08-05 | 2 |
| ANDA 219054 | XGEN PHARMS | 2026-03-16 | 1 |
Official labeling on DailyMed
- ERIBULIN MESYLATE INJECTION [APOTEX CORP.] · version 3 · 2026-09-02
- ERIBULIN MESYLATE INJECTION [GLAND PHARMA LIMITED] · version 5 · 2026-07-22
- HALAVEN (ERIBULIN MESYLATE) INJECTION [BSP PHARMACEUTICALS SPA] · version 58 · 2026-05-14
- ERIBULIN MESYLATE INJECTION [XGEN PHARMACEUTICALS DJB, INC.] · version 1 · 2026-04-08
- ERIBULIN MESYLATE SOLUTION [BLUEPOINT LABORATORIES] · version 2 · 2026-03-26
- ERIBULIN MESYLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 9 · 2026-02-27
- ERIBULIN MESYLATE INJECTION [BAXTER HEALTHCARE COMPANY] · version 4 · 2026-02-26
- ERIBULIN MESYLATE INJECTION [DR. REDDYS LABORATORIES INC] · version 5 · 2026-01-23
- ERIBULIN MESYLATE SOLUTION [NORTHSTAR RX LLC] · version 1 · 2025-12-05
- HALAVEN (ERIBULIN MESYLATE) INJECTION [EISAI INC.] · version 69 · 2025-11-17
- ERIBULIN MESYLATE INJECTION [GLENMARK PHARMACEUTICALS INC., USA] · version 2 · 2025-10-06
- ERIBULIN MESYLATE INJECTION [KINDOS PHARMACEUTICALS CO., LTD.] · version 4 · 2025-08-22
Showing the 12 most recent of 16 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.