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FDA NDA · NDA214787

VEKLURY

remdesivir

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA214787
TYPE
NDA
ORIGINAL APPROVAL
2020-10-22
LATEST ACTION
2026-07-29
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION, POWDER
MARKETING STATUS
Discontinued, Prescription

Products

VEKLURY · ReferenceDiscontinued
REMDESIVIR 100MG/20ML (5MG/ML) · SOLUTION · INTRAVENOUS
VEKLURY · ReferencePrescription
REMDESIVIR 100MG/VIAL · POWDER · INTRAVENOUS

Approval history

2026-07-29Labeling · Supplement 33 · standard — Letter ↗AP
2025-10-07Labeling · Supplement 32 · standard — Label ↗AP
2025-08-22Labeling · Supplement 31 · standard — Label ↗AP
2025-01-10Labeling · Supplement 30 · standard — Letter ↗AP
2024-12-19Labeling · Supplement 29 · standard — Letter ↗AP
2024-06-27Labeling · Supplement 27 · standard — Label ↗AP
2024-02-28Efficacy · Supplement 26 · priority — Label ↗AP
2023-08-23Labeling · Supplement 24 · standard — Label ↗AP
2023-08-17Labeling · Supplement 25 · standard — Letter ↗AP
2023-07-13Efficacy · Supplement 19 · priority — Label ↗AP
2023-06-12Labeling · Supplement 21 · standard — Letter ↗AP
2023-06-07Labeling · Supplement 23 · standard — Letter ↗AP
2023-04-28Labeling · Supplement 22 · standard — Letter ↗AP
2023-03-29Labeling · Supplement 18 · standard — Letter ↗AP
2022-12-15Labeling · Supplement 20 · standard — Letter ↗AP
2022-10-24Labeling · Supplement 16 · standard — Letter ↗AP
2022-09-29Labeling · Supplement 14 · standard — Letter ↗AP
2022-06-24Labeling · Supplement 15 · standard — Letter ↗AP
2022-04-25Efficacy · Supplement 11 · priority — Letter ↗AP
2022-03-24Labeling · Supplement 13 · standard — Letter ↗AP
2022-01-21Efficacy · Supplement 10 · priority — Label ↗AP
2022-01-19Labeling · Supplement 9 · standard — Letter ↗AP
2021-02-22Labeling · Supplement 5 · standard — Letter ↗AP
2020-10-22Type 1 - New Molecular Entity · Original · priority — Summary Review ↗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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