Treats idiopathic pulmonary fibrosis (IPF). ANDA 212560, held by Sandoz. Pirfenidone.
As of Nov 14, 2026, ANDA 212560 (Pirfenidone), held by Sandoz, was first approved by FDA on Apr 28, 2022, with 1 approved supplement and 0 published complete response letters.
Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 28, 2022 | Original application | Approved |
| Pirfenidone267MG · tablet;oral | Pirfenidone | Rx |
| Pirfenidone801MG · tablet;oral | Pirfenidone | Rx |
| Aug 7, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 28, 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
