Active ingredient
Isatuximab
3 finished FDA listings contain Isatuximab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ISATUXIMAB
- Dosage forms
- Injection, Solution, Injection, Solution, Concentrate
- Routes
- Intravenous, Subcutaneous
- Manufacturers / labelers
- 1
- Strengths listed
- 100 mg/5ml · 140 mg/ml · 500 mg/25ml
- Brand names in FDA listings
- Sarclisa, Sarclisa Escena
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2282018
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 761113 | SANOFI AVENTIS US | 2020-03-02 | 2 |
| BLA 761445 | SANOFI-AVENTIS U.S. LLC | 2026-07-09 | 1 |
Official labeling on DailyMed
- SARCLISA ESCENA (ISATUXIMAB-IRFC) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC] · version 3 · 2026-07-13
- SARCLISA (ISATUXIMAB) INJECTION, SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC] · version 20 · 2026-07-09
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.