Treats idiopathic pulmonary fibrosis (IPF). ANDA 212680, held by Micro Labs. Pirfenidone.
As of Nov 14, 2026, ANDA 212680 (Pirfenidone), held by Micro Labs, was first approved by FDA on May 18, 2022, with 1 approved supplement and 0 published complete response letters.
Pirfenidone tablet is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 18, 2022 | Original application | Approved |
| Pirfenidone267MG · tablet;oral | Pirfenidone | Rx |
| Pirfenidone801MG · tablet;oral | Pirfenidone | Rx |
| Pirfenidone534MG · tablet;oral | Pirfenidone | Rx |
| Sep 12, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 18, 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
