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NILOTINIB HYDROCHLORIDE

ANDA

NILOTINIB HYDROCHLORIDE | A209651 | HETERO LABS LTD UNIT V

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: TASIGNA(TE code: AB)

API Supply Chain15 active DMFs3 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

TEVA PHARMACEUTICAL INDUSTRIES LTDNILOTINIB HYDROCHLORIDE

DMF 281022014

DR REDDYS LABORATORIES LTDNILOTINIB HYDROCHLORIDE

DMF 300882015

HETERO LABS LTDNILOTINIB HYDROCHLORIDE DIHYDRATE

DMF 300982015

SUZHOU LIXIN PHARMACEUTICAL CO LTDNILOTINIB HYDROCHLORIDE MONOHYDRATE

DMF 316932017

MSN LABORATORIES PRIVATE LTDNILOTINIB HYDROCHLORIDE (MONOHYDRATE)

DMF 326612018

MSN LABORATORIES PRIVATE LTDNILOTINIB

DMF 331962018

TEVA PHARMACEUTICAL INDUSTRIES LTDNILOTINIB HYDROCHLORIDE FORM ALPHA

DMF 348742020

MSN LABORATORIES PRIVATE LTDNILOTINIB HYDROCHLORIDE SESQUIHYDRATE

DMF 357292021

SHILPA PHARMA LIFESCIENCES LTDNILOTINIB

DMF 362892021

NATCO PHARMA LTDNILOTINIB HYDROCHLORIDE MONOHYDRATE

DMF 363082022

DR REDDYS LABORATORIES LTDNILOTINIB HYDROCHLORIDE MONOHYDRATE

DMF 371612022

GRANULES INDIA LTD (UNIT-V)NILOTINIB HYDROCHLORIDE MONOHYDRATE

DMF 375312022

SICHUAN ELIXIR PHARMACEUTICAL CO LTDNILOTINIB

DMF 396482024

SHANDONG LIXIN PHARMACEUTICAL CO LTDNILOTINIB HYDROCHLORIDE MONOHYDRATE

DMF 400142024

MSN LABORATORIES PRIVATE LTDNILOTINIB HYDROCHLORIDE (MONOHYDRATE) [ROUTE CODE NPH]

DMF 413182025

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveNILOTINIB HYDROCHLORIDE MONOHYDRATE (FORM B) (VERSION NO.: 1)

DMF 253382011

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveNILOTINIB HYDROCHLORIDE MONOHYDRATE (VERSION NO.: 1)

DMF 254122011

SICHUAN XIELI PHARMACEUTICAL CO LTDInactiveNILOTINIB

DMF 264972012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 10, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 150MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Nov 19, 2025

No patent or exclusivity listings for this strength.

#002 — EQ 200MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 19, 2025