Active ingredient
Erdafitinib
3 finished FDA listings contain Erdafitinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ERDAFITINIB
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 3 mg/1 · 4 mg/1 · 5 mg/1
- Brand names in FDA listings
- Balversa
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2123125
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 212018 | JANSSEN BIOTECH | 2019-04-12 | 3 |
Official labeling on DailyMed
- BALVERSA (ERDAFITINIB) TABLET, FILM COATED [JANSSEN PRODUCTS LP] · version 14 · 2025-11-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.