ANDA 212747, held by Aizant. Pirfenidone.
As of Nov 14, 2026, ANDA 212747 (Pirfenidone), held by Aizant, was first approved by FDA on Jul 21, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 21, 2022 | Original application | Approved |
| Pirfenidone267MG · tablet;oral | Pirfenidone | Rx |
| Pirfenidone534MG · 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
