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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209651
Company: HETERO LABS LTD V

Products on ANDA 209651

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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
NILOTINIB HYDROCHLORIDE DIHYDRATE	NILOTINIB HYDROCHLORIDE DIHYDRATE	150MG	CAPSULE	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209651

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/19/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209651Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 209651

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

NILOTINIB HYDROCHLORIDE DIHYDRATE

There are no Therapeutic Equivalents.

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