ANDA 218532, held by Torrent. Nilotinib Hydrochloride, Nilotinib.
As of Nov 15, 2026, ANDA 218532 (Nilotinib Hydrochloride, Nilotinib), held by Torrent, was first approved by FDA on Dec 15, 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 |
|---|---|---|---|
| Dec 15, 2025 | Original application | Approved | None posted |
| Nilotinib HydrochlorideEQ 150MG BASE · capsule;oral | Nilotinib Hydrochloride | Rx |
| Nilotinib HydrochlorideEQ 200MG BASE · capsule;oral | Nilotinib Hydrochloride | Rx |
| Nilotinib200MG · capsule | Nilotinib | None (tentative approval) |
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
