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NILOTINIB HYDROCHLORIDE

ANDA

NILOTINIB HYDROCHLORIDE | A219134 | TEVA PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: TASIGNA(TE code: AB)

API Supply Chain12 active DMFs2 inactive

8 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

TEVA PHARMACEUTICAL INDUSTRIES LTDNILOTINIB HYDROCHLORIDE FORM ALPHA

DMF 348742020

MSN LABORATORIES PRIVATE LTDNILOTINIB HYDROCHLORIDE SESQUIHYDRATE

DMF 357292021

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

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

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

Products (3)

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#001 — EQ 50MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jun 26, 2026

No patent or exclusivity listings for this strength.

#002 — EQ 150MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jun 26, 2026

#003 — EQ 200MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jun 26, 2026