Treats idiopathic pulmonary fibrosis (IPF). ANDA 212759, held by Teva Pharms USA. Pirfenidone.
As of Nov 14, 2026, ANDA 212759 (Pirfenidone), held by Teva Pharms USA, was first approved by FDA on Jan 25, 2022, with 2 approved supplements and 0 published complete response letters.
Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 2022 | Original application | Approved |
| Pirfenidone267MG · tablet;oral | Pirfenidone | Rx |
| Pirfenidone801MG · tablet;oral | Pirfenidone | Rx |
| Nov 26, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 11, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 25, 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
