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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203640
Company: APOTEX

Products on ANDA 203640

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	AB	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 203640

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/05/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203640Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 203640

NILOTINIB HYDROCHLORIDE

CAPSULE;ORAL; EQ 50MG 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 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	203640	APOTEX
TASIGNA	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	022068	NOVARTIS

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
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
TASIGNA	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	022068	NOVARTIS

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