Details for New Drug Application (NDA): 218532

NDA 218532 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 218532

Tradename:	NILOTINIB HYDROCHLORIDE
Applicant:	Torrent
Ingredient:	nilotinib hydrochloride
Patents:	0

Pharmacology for NDA: 218532

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: 218532

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NILOTINIB HYDROCHLORIDE	nilotinib hydrochloride	CAPSULE;ORAL	218532	ANDA	Torrent Pharmaceuticals Limited	13668-710	13668-710-57	4 BLISTER PACK in 1 CARTON (13668-710-57) / 28 CAPSULE in 1 BLISTER PACK
NILOTINIB HYDROCHLORIDE	nilotinib hydrochloride	CAPSULE;ORAL	218532	ANDA	Torrent Pharmaceuticals Limited	13668-710	13668-710-91	1 BLISTER PACK in 1 CARTON (13668-710-91) / 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:	Dec 15, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Dec 15, 2025	TE:	AB	RLD:	No

Complete Access Available with Subscription