Treats idiopathic pulmonary fibrosis (IPF). ANDA 212600, held by Sandoz. Pirfenidone.
As of Nov 14, 2026, ANDA 212600 (Pirfenidone), held by Sandoz, was first approved by FDA on Jun 13, 2022, with 1 approved supplement and 0 published complete response letters.
Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 13, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pirfenidone267MG · capsule;oral | Pirfenidone | Rx |
| Aug 7, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 13, 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
