Active ingredient
Axatilimab
4 finished FDA listings contain Axatilimab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- AXATILIMAB
- Dosage forms
- Injection
- Routes
- Intravenous
- Manufacturers / labelers
- 1
- Strengths listed
- 22 mg/.44ml · 22 mg/2.2ml · 9 mg/.18ml · 9 mg/.9ml
- Brand names in FDA listings
- Niktimvo
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2691526
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 |
|---|---|---|---|
| BLA 761411 | INCYTE CORP | 2024-08-14 | 4 |
Official labeling on DailyMed
No DailyMed labels matched by set ID.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.