Treats idiopathic pulmonary fibrosis (IPF). ANDA 212708, held by Alembic. Pirfenidone.
As of Nov 14, 2026, ANDA 212708 (Pirfenidone), held by Alembic, was first approved by FDA on May 20, 2022, with 1 approved supplement and 0 published complete response letters.
Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 20, 2022 | Original application | Approved |
| Pirfenidone267MG · tablet;oral | Pirfenidone | Rx |
| Pirfenidone801MG · tablet;oral | Pirfenidone | Rx |
| Aug 7, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 20, 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
