APPLICATION
NDA215319
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
FILM
MARKETING STATUS
Prescription
Products
DOLUTEGRAVIRPrescription
DOLUTEGRAVIR 5MG · FILM · ORAL
DOLUTEGRAVIRPrescription
DOLUTEGRAVIR 10MG · FILM · ORAL
Approval history
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.