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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 220018
Company: GILEAD SCIENCES INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
YEZTUGO LENACAPAVIR SODIUM EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
YEZTUGO LENACAPAVIR 463.5MG/1.5ML(309MG/ML) SOLUTION;SUBCUTANEOUS Prescription None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/18/2025 ORIG-1 Approval PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220018s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/220018Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/220018Orig1s000TOC.html

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/18/2025 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220018s000lbl.pdf
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