Treats idiopathic pulmonary fibrosis (IPF). ANDA 212724, held by Laurus. Pirfenidone.
As of Nov 14, 2026, ANDA 212724 (Pirfenidone), held by Laurus, was first approved by FDA on Jul 19, 2022, with 1 approved supplement and 0 published complete response letters.
Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 19, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pirfenidone267MG · capsule;oral | Pirfenidone | Rx |
| Dec 14, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 19, 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
