ANDA 218544, held by Msn. Nilotinib Hydrochloride.
As of Nov 15, 2026, ANDA 218544 (Nilotinib Hydrochloride), held by Msn, was first approved by FDA on Nov 19, 2025, with 0 approved supplements and 0 published complete response letters.
Nilotinib capsules are a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 19, 2025 | Original application | Approved | None posted |
| Nilotinib HydrochlorideEQ 50MG BASE · capsule;oral | Nilotinib Hydrochloride | Rx |
| Nilotinib HydrochlorideEQ 150MG BASE · capsule;oral | Nilotinib Hydrochloride | Rx |
| Nilotinib HydrochlorideEQ 200MG BASE · capsule;oral | Nilotinib Hydrochloride | 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
