Treats idiopathic pulmonary fibrosis (IPF). ANDA 212772, held by Msn. Pirfenidone.
As of Nov 14, 2026, ANDA 212772 (Pirfenidone), held by Msn, was first approved by FDA on May 24, 2022, with 1 approved supplement and 0 published complete response letters.
Pirfenidone tablet is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 24, 2022 | Original application | Approved |
| Pirfenidone267MG · tablet;oral | Pirfenidone | Rx |
| Pirfenidone801MG · tablet;oral | Pirfenidone | Rx |
| Aug 7, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 24, 2022 | Original application | Approved |
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
