APPLICATION
NDA220018
TYPE
NDA
ORIGINAL APPROVAL
2025-06-18
LATEST ACTION
2025-06-18
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
YEZTUGOPrescription
LENACAPAVIR 463.5MG/1.5ML(309MG/ML) · SOLUTION · SUBCUTANEOUS
YEZTUGO · ReferencePrescription
LENACAPAVIR SODIUM EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) · SOLUTION · SUBCUTANEOUS
Approval history
2025-06-18Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated · Original · priority — Label ↗AP
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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