# PIRFENIDONE
> **ANDA212597** · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2026-04-20
## Drug
- **FDA Application Number:** ANDA212597
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** PIRFENIDONE
- **Generic name:** PIRFENIDONE
- **Active ingredients:** PIRFENIDONE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** AUROBINDO PHARMA
- **Manufacturer:** Aurobindo Pharma Limited
- **First approval:** 2026-04-20
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212597)
---
*AI Analytics · CC0 1.0*