# BALVERSA
> **NDA212018** · New Drug Application · Sponsor: JANSSEN BIOTECH · Approved 2019-04-12
## Drug
- **FDA Application Number:** NDA212018
- **Application type:** New Drug Application
- **Brand name:** BALVERSA
- **Generic name:** ERDAFITINIB
- **Active ingredients:** ERDAFITINIB
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** JANSSEN BIOTECH
- **Manufacturer:** Janssen Products LP
- **First approval:** 2019-04-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212018)
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