Details for New Drug Application (NDA): 209651

NDA 209651 describes NILOTINIB HYDROCHLORIDE, which is a drug marketed by Apotex, Dr Reddys, Hetero Labs Ltd V, MSN, and Torrent, and is included in five NDAs. It is available from six suppliers. Additional details are available on the NILOTINIB HYDROCHLORIDE profile page.

The generic ingredient in NILOTINIB HYDROCHLORIDE is nilotinib hydrochloride. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the nilotinib hydrochloride profile page.

Summary for 209651

Tradename:	NILOTINIB HYDROCHLORIDE
Applicant:	Hetero Labs Ltd V
Ingredient:	nilotinib hydrochloride
Patents:	0

Pharmacology for NDA: 209651

Mechanism of Action

Bcr-Abl Tyrosine Kinase Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors P-Glycoprotein Inhibitors UGT1A1 Inhibitors

Suppliers and Packaging for NDA: 209651

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NILOTINIB HYDROCHLORIDE	nilotinib hydrochloride	CAPSULE;ORAL	209651	ANDA	Camber Pharmaceuticals, Inc.	31722-779	31722-779-33	4 BLISTER PACK in 1 CARTON (31722-779-33) / 28 CAPSULE in 1 BLISTER PACK
NILOTINIB HYDROCHLORIDE	nilotinib hydrochloride	CAPSULE;ORAL	209651	ANDA	Camber Pharmaceuticals, Inc.	31722-780	31722-780-33	4 BLISTER PACK in 1 CARTON (31722-780-33) / 28 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Nov 19, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Nov 19, 2025	TE:	AB	RLD:	No

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