Nilotinib Hydrochloride, Nilotinib Hydrochloride Dihydrate

ANDA 209651, held by Hetero Labs Ltd V. Nilotinib Hydrochloride, Nilotinib Hydrochloride Dihydrate.

As of Nov 15, 2026, ANDA 209651 (Nilotinib Hydrochloride, Nilotinib Hydrochloride Dihydrate), held by Hetero Labs Ltd V, was first approved by FDA on Nov 19, 2025, with 0 approved supplements and 0 published complete response letters.

First approved: Nov 19, 2025
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Nilotinib is 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 and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Nov 19, 2025	Original application	Approved	Letter

Products

3 strengths and forms


Nilotinib HydrochlorideEQ 150MG BASE · capsule;oral	Nilotinib Hydrochloride	Rx
Nilotinib HydrochlorideEQ 200MG BASE · capsule;oral	Nilotinib Hydrochloride	Rx
Nilotinib Hydrochloride Dihydrate150MG · capsule	Nilotinib Hydrochloride Dihydrate	None (tentative approval)

Identifiers

Application: ANDA 209651
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd

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