Treats idiopathic pulmonary fibrosis (IPF). ANDA 212596, held by Aurobindo Pharma. Pirfenidone.
As of Nov 14, 2026, ANDA 212596 (Pirfenidone), held by Aurobindo Pharma, was first approved by FDA on Aug 11, 2025, with 0 approved supplements and 0 published complete response letters.
Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 11, 2025 | Original application | Approved | None posted |
| Pirfenidone267MG · tablet;oral | Pirfenidone | Rx |
| Pirfenidone801MG · tablet;oral | Pirfenidone | Rx |
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
