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FDA NDA · NDA205858

ZYDELIG

idelalisib

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA205858
TYPE
NDA
ORIGINAL APPROVAL
2014-07-23
LATEST ACTION
2022-07-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ZYDELIG · ReferencePrescription
IDELALISIB 150MG · TABLET · ORAL
ZYDELIG · ReferencePrescription
IDELALISIB 100MG · TABLET · ORAL

Approval history

2022-07-06REMS · Supplement 18 — Letter ↗AP
2022-03-10REMS · Supplement 17 — Letter ↗AP
2022-02-18Labeling · Supplement 16 · standard — Label ↗AP
2020-10-19Labeling · Supplement 14 · standard — Label ↗AP
2018-10-10Labeling · Supplement 13 · standard — Label ↗AP
2018-03-22REMS · Supplement 12 — Letter ↗AP
2018-02-06REMS · Supplement 10 — Letter ↗AP
2018-02-02Labeling · Supplement 11 · standard — Label ↗AP
2018-01-26Labeling · Supplement 9 · standard — Label ↗AP
2017-11-29Labeling · Supplement 7 · standard — Label ↗AP
2017-01-04REMS · Supplement 5 — Letter ↗AP
2016-09-21Labeling · Supplement 4 · standard — Letter ↗AP
2016-01-19Manufacturing (CMC) · Supplement 3 · standardAP
2015-09-01Manufacturing (CMC) · Supplement 1 · standardAP
2014-07-23Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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