An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216921
Company: NATCO

Products on ANDA 216921

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IDELALISIB	IDELALISIB	100MG	TABLET;ORAL	Prescription	AB	No	No
IDELALISIB	IDELALISIB	150MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216921

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216921

IDELALISIB

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IDELALISIB	IDELALISIB	100MG	TABLET;ORAL	Prescription	No	AB	216921	NATCO
ZYDELIG	IDELALISIB	100MG	TABLET;ORAL	Prescription	Yes	AB	205858	GILEAD SCIENCES INC

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IDELALISIB	IDELALISIB	150MG	TABLET;ORAL	Prescription	No	AB	216921	NATCO
ZYDELIG	IDELALISIB	150MG	TABLET;ORAL	Prescription	Yes	AB	205858	GILEAD SCIENCES INC

Top