Active ingredient
Spesolimab
6 finished FDA listings contain Spesolimab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SPESOLIMAB
- Dosage forms
- Injection
- Routes
- Intravenous, Subcutaneous
- Manufacturers / labelers
- 2
- Strengths listed
- 150 mg/1 · 150 mg/ml · 300 mg/1 · 300 mg/2ml · 60 mg/ml
- Brand names in FDA listings
- Spevigo
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2610417
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 761244 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | 2022-09-01 | 6 |
Official labeling on DailyMed
- SPEVIGO (SPESOLIMAB-SBZO) INJECTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] · version 7 · 2026-06-18
- SPEVIGO (SPESOLIMAB) INJECTION [LEO PHARMA INC.] · version 2 · 2026-03-19
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.