Treats idiopathic pulmonary fibrosis (IPF). ANDA 212078, held by Sciegen Pharms. Pirfenidone.
As of Nov 14, 2026, ANDA 212078 (Pirfenidone), held by Sciegen Pharms, was first approved by FDA on Aug 1, 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 |
|---|---|---|---|
| Aug 1, 2022 | Original application | Approved |
| Pirfenidone267MG · tablet;oral | Pirfenidone | Rx |
| Pirfenidone801MG · tablet;oral | Pirfenidone | Rx |
| Apr 12, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 1, 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
