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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214787
Company: GILEAD SCIENCES INC

Summary Review

Products on NDA 214787

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VEKLURY	REMDESIVIR	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes
VEKLURY	REMDESIVIR	100MG/20ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214787

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/22/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214787Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214787Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214787Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214787Orig1s000Sumr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2024	SUPPL-26	Efficacy-New Patient Population	Label (PDF) Letter (PDF) Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214787s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214787Orig1s026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2024/214787Orig1s026SumR.pdf
08/17/2023	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214787Orig1s025ltr.pdf
08/23/2023	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214787Orig1s024ltr.pdf
06/07/2023	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214787orig1s023ltr.pdf
04/28/2023	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214787Orig1s022ltr.pdf
06/12/2023	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214787Orig1s021ltr.pdf
12/15/2022	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s020ltr.pdf
07/13/2023	SUPPL-19	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214787Orig1s019ltr.pdf
03/29/2023	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214787Orig1s018ltr.pdf
10/24/2022	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s016ltr.pdf
06/24/2022	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s015ltr.pdf
09/29/2022	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s014ltr.pdf
03/24/2022	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s013ltr.pdf
04/25/2022	SUPPL-11	Efficacy-New Patient Population	Label (PDF) Letter (PDF) Review (PDF) Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214787Orig1s011.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214787Orig1s011JointReview.pdf
01/21/2022	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF) Review (PDF) Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787Orig1s010Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214787Orig1s010.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214787Orig1s010JointReview.pdf
01/19/2022	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s009ltr.pdf
02/22/2021	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214787s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214787Orig1s005ltr.pdf

Labels for NDA 214787

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2024	SUPPL-26	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214787s026lbl.pdf
08/23/2023	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s024lbl.pdf
08/17/2023	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s025lbl.pdf
07/13/2023	SUPPL-19	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s019lbl.pdf
06/12/2023	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s021lbl.pdf
06/07/2023	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s023lbl.pdf
04/28/2023	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s022lbl.pdf
03/29/2023	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s018lbl.pdf
12/15/2022	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787Orig1s020lbl.pdf
10/24/2022	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s016lbl.pdf
09/29/2022	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s014lbl.pdf
06/24/2022	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787Orig1s015lbl.pdf
04/25/2022	SUPPL-11	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s011lbl.pdf
03/24/2022	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s013lbl.pdf
01/21/2022	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787Orig1s010Lbl.pdf
01/19/2022	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s009lbl.pdf
02/22/2021	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214787s005lbl.pdf
10/22/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214787Orig1s000lbl.pdf

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