Treats idiopathic pulmonary fibrosis (IPF). ANDA 212722, held by Laurus. Pirfenidone.
As of Nov 14, 2026, ANDA 212722 (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 |
| Pirfenidone267MG · tablet;oral | Pirfenidone | Rx |
| Pirfenidone534MG · tablet;oral | Pirfenidone | Rx |
| Pirfenidone801MG · tablet;oral | Pirfenidone | Rx |
| Dec 14, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 19, 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
