ANDA 211182, held by Hetero Labs Ltd V. Ibrutinib.
As of Nov 15, 2026, ANDA 211182 (Ibrutinib), held by Hetero Labs Ltd V, was first approved by FDA on Sep 8, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 8, 2026 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ibrutinib140MG ยท capsule;oral | Ibrutinib | 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
