APPLICATION
NDA216964
TYPE
NDA
ORIGINAL APPROVAL
2026-04-20
LATEST ACTION
2026-04-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IDVYNSO · ReferencePrescription
DORAVIRINE 100MG, ISLATRAVIR 0.25MG · TABLET · ORAL
Approval history
2026-04-20Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Letter ↗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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