Last Updated: November 9, 2026

Details for New Drug Application (NDA): 211182

NDA 211182 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 211182

Tradename:	IBRUTINIB
Applicant:	Hetero Labs Ltd V
Ingredient:	ibrutinib
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	140MG
Approval Date:	Sep 8, 2026	TE:	AB	RLD:	No

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