Treats idiopathic pulmonary fibrosis (IPF). ANDA 212709, held by Apotex. Pirfenidone.
As of Nov 14, 2026, ANDA 212709 (Pirfenidone), held by Apotex, was first approved by FDA on May 31, 2023, 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 |
|---|---|---|---|
| May 31, 2023 | Original application | Approved |
| 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
