Active ingredient
Larotrectinib
7 finished FDA listings contain Larotrectinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LAROTRECTINIB, LAROTRECTINIB SULFATE
- Dosage forms
- Capsule, Solution, Solution, Concentrate
- Routes
- Oral, Oropharyngeal
- Manufacturers / labelers
- 2
- Strengths listed
- 100 mg/1 · 20 mg/ml · 25 mg/1
- Brand names in FDA listings
- Vitrakvi
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2105628
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 210861 | BAYER HLTHCARE | 2018-11-26 | 4 |
| NDA 211710 | BAYER HEALTHCARE | 2018-11-26 | 3 |
Official labeling on DailyMed
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.