# PIRFENIDONE
> **ANDA212615** · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES INDIA · Approved 2021-05-12
## Drug
- **FDA Application Number:** ANDA212615
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** PIRFENIDONE
- **Generic name:** Pirfenidone
- **Active ingredients:** PIRFENIDONE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** GRANULES INDIA
- **First approval:** 2021-05-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212615)
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