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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214787
Company: GILEAD SCIENCES INC
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
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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