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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218532
Company: TORRENT

Products on ANDA 218532

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NILOTINIB	NILOTINIB	200MG	CAPSULE	None (Tentative Approval)	None	No	No
NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218532

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218532

NILOTINIB

There are no Therapeutic Equivalents.

NILOTINIB HYDROCHLORIDE

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	203640	APOTEX
NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	218350	DR REDDYS
NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	209651	HETERO LABS LTD V
NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	218544	MSN
NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	218532	TORRENT
TASIGNA	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	022068	NOVARTIS

CAPSULE;ORAL; EQ 200MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	No	AB	203640	APOTEX
NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	No	AB	218350	DR REDDYS
NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	No	AB	209651	HETERO LABS LTD V
NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	No	AB	218544	MSN
NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	No	AB	218532	TORRENT
TASIGNA	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	022068	NOVARTIS

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