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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 221443
Company: GILEAD SCIENCES INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) BICTEGRAVIR SODIUM, LENACAPAVIR SODIUM; LENACAPAVIR SODIUM EQ 75MG BASE, EQ 50MG BASE; EQ 300MG BASE TABLET;ORAL 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
08/27/2026 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/221443Orig1s000correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/221443Orig1s000correctedltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/27/2026 SUPPL-1 Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/221443Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/27/2026 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/221443Orig1s000correctedlbl.pdf
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