Drug application

NILOTINIB HYDROCHLORIDE (NILOTINIB HYDROCHLORIDE)

Drugs@FDA ANDA 218532 · TORRENT

Key facts

Drug name NILOTINIB HYDROCHLORIDE
Active ingredients NILOTINIB HYDROCHLORIDE
Application type ANDA
Application number 218532
Company TORRENT
Dosage forms CAPSULE, ORAL
Strength EQ 150MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Dec 15, 2025

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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