Last Updated: November 9, 2026

Details for New Drug Application (NDA): 211344

NDA 211344 describes IBRUTINIB, which is a drug marketed by Hetero Labs Ltd V and Zydus Lifesciences and is included in two NDAs. Additional details are available on the IBRUTINIB profile page.

The generic ingredient in IBRUTINIB is ibrutinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.

Summary for 211344

Tradename:	IBRUTINIB
Applicant:	Zydus Lifesciences
Ingredient:	ibrutinib
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	70MG
Approval Date:	Mar 31, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	140MG
Approval Date:	Mar 31, 2021	TE:		RLD:	No

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