Treats idiopathic pulmonary fibrosis (IPF). ANDA 212570, held by Amneal. Pirfenidone.
As of Nov 14, 2026, ANDA 212570 (Pirfenidone), held by Amneal, was first approved by FDA on Mar 25, 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 |
|---|---|---|---|
| Mar 25, 2022 | Original application | Approved | None posted |
| Pirfenidone267MG · tablet;oral | Pirfenidone | Rx |
| Pirfenidone801MG · tablet;oral | Pirfenidone | Rx |
| Aug 7, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 25, 2022 | Original application | Approved | None posted |
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
