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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205858
Company: GILEAD SCIENCES INC

Medication Guide

Summary Review

Products on NDA 205858

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZYDELIG	IDELALISIB	100MG	TABLET;ORAL	Prescription	None	Yes	No
ZYDELIG	IDELALISIB	150MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205858

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/23/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205858lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205858Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205858Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205858Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/06/2022	SUPPL-18	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205858Orig1s018ltr.pdf
03/10/2022	SUPPL-17	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205858Orig1s017ltr.pdf
02/18/2022	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205858s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205858Orig1s016ltr.pdf
10/19/2020	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205858s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205858Orig1s014ltr.pdf
10/10/2018	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s013ltr.pdf
03/22/2018	SUPPL-12	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s012ltr.pdf
02/02/2018	SUPPL-11	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s011ltr.pdf
02/06/2018	SUPPL-10	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s010ltr.pdf
01/26/2018	SUPPL-9	REMS - MODIFIED - D-N-A, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s009ltr.pdf
11/29/2017	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205858s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205858Orig1s007ltr.pdf
01/04/2017	SUPPL-5	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205858Orig1s005ltr.pdf
09/21/2016	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205858s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205858Orig1s004ltr.pdf
01/19/2016	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/01/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 205858

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/18/2022	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205858s016lbl.pdf
10/19/2020	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205858s014lbl.pdf
10/19/2020	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205858s014lbl.pdf
10/10/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s013lbl.pdf
02/02/2018	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s011lbl.pdf
01/26/2018	SUPPL-9	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s009lbl.pdf
01/26/2018	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s009lbl.pdf
11/29/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205858s007lbl.pdf
09/21/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205858s004lbl.pdf
09/21/2016	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205858s004lbl.pdf
07/23/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205858lbl.pdf

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