Treats idiopathic pulmonary fibrosis (IPF). ANDA 212674, held by Hetero Labs Ltd V. Pirfenidone.
As of Nov 14, 2026, ANDA 212674 (Pirfenidone), held by Hetero Labs Ltd V, was first approved by FDA on Sep 21, 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 |
|---|---|---|---|
| Sep 21, 2022 | Original application | Approved | None posted |
| Pirfenidone267MG · tablet;oral | Pirfenidone | Rx |
| Pirfenidone801MG · tablet;oral | Pirfenidone | Rx |
| Aug 7, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 21, 2022 | Original application | Approved | None posted |
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
