ANDA 209728, held by Actavis Labs Fl. Regorafenib.
As of Nov 14, 2026, ANDA 209728 (Regorafenib), held by Actavis Labs Fl, was first approved by FDA on Jan 13, 2025, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 13, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Regorafenib40MG · tablet;oral | Regorafenib | Discontinued |
| Jul 18, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 13, 2025 | 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
