Treats idiopathic pulmonary fibrosis (IPF). ANDA 212748, held by Macleods Pharms. Pirfenidone.
As of Nov 14, 2026, ANDA 212748 (Pirfenidone), held by Macleods Pharms, was first approved by FDA on Dec 18, 2024, with 0 approved supplements and 0 published complete response letters.
Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 18, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pirfenidone267MG · capsule;oral | Pirfenidone | Rx |
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
