ANDA 212404, held by Chartwell Rx. Pirfenidone.
As of Nov 14, 2026, ANDA 212404 (Pirfenidone), held by Chartwell Rx, was first approved by FDA on Aug 28, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pirfenidone267MG ยท capsule;oral | Pirfenidone | Discontinued |
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
