ANDA 211344, held by Zydus Lifesciences. Ibrutinib.
As of Nov 15, 2026, ANDA 211344 (Ibrutinib), held by Zydus Lifesciences, was first approved by FDA on Mar 31, 2021, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 31, 2021 | Original application | Approved |
| Feb 5, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 31, 2021 | 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
