Treats idiopathic pulmonary fibrosis (IPF). ANDA 212597, held by Aurobindo Pharma. Pirfenidone.
As of Nov 14, 2026, ANDA 212597 (Pirfenidone), held by Aurobindo Pharma, was first approved by FDA on Apr 20, 2026, with 0 approved supplements and 0 published complete response letters.
Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 20, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pirfenidone267MG · capsule;oral | Pirfenidone | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
