Last Updated: May 11, 2026

Details for New Drug Application (NDA): 216921

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NDA 216921 describes IDELALISIB, which is a drug marketed by Natco and is included in one NDA. Additional details are available on the IDELALISIB profile page.

The generic ingredient in IDELALISIB is idelalisib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the idelalisib profile page.

Summary for 216921

Tradename:	IDELALISIB
Applicant:	Natco
Ingredient:	idelalisib
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Feb 17, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Feb 17, 2026	TE:	AB	RLD:	No

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