Treats idiopathic pulmonary fibrosis (IPF). ANDA 212569, held by Amneal. Pirfenidone.
As of Nov 14, 2026, ANDA 212569 (Pirfenidone), held by Amneal, was first approved by FDA on Jan 3, 2022, with 2 approved supplements and 0 published complete response letters.
Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 3, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pirfenidone267MG · capsule;oral | Pirfenidone | Rx |
| Aug 7, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 11, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 3, 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
