# NINTEDANIB ESYLATE
> **ANDA219227** · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX · Approved 2026-04-02
## Drug
- **FDA Application Number:** ANDA219227
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** NINTEDANIB ESYLATE
- **Generic name:** NINTEDANIB
- **Active ingredients:** NINTEDANIB ESYLATE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** APOTEX
- **Manufacturer:** Apotex Corp.
- **First approval:** 2026-04-02
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219227)
---
*AI Analytics · CC0 1.0*