Last Updated: August 9, 2026

Details for New Drug Application (NDA): 219134

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NDA 219134 describes NILOTINIB HYDROCHLORIDE, which is a drug marketed by Apotex, Dr Reddys, Hetero Labs Ltd V, MSN, Teva Pharms Inc, and Torrent, and is included in six 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 219134

Tradename:	NILOTINIB HYDROCHLORIDE
Applicant:	Teva Pharms Inc
Ingredient:	nilotinib hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 50MG BASE
Approval Date:	Jun 26, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Jun 26, 2026	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Jun 26, 2026	TE:	AB	RLD:	No

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