← FDA DRUG APPROVALS

FDA NDA · NDA210806

PIFELTRO

doravirine

Sponsor: MSD MERCK CO

APPLICATION
NDA210806
TYPE
NDA
ORIGINAL APPROVAL
2018-08-30
LATEST ACTION
2025-10-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PIFELTRO · ReferencePrescription
DORAVIRINE 100MG · TABLET · ORAL

Approval history

2025-10-29Labeling · Supplement 13 · standard — Label ↗AP
2024-11-07Labeling · Supplement 11 · standard — Label ↗AP
2022-01-27Efficacy · Supplement 7 · priority — Label ↗AP
2019-10-10Efficacy · Supplement 3 · standard — Letter ↗AP
2019-09-19Efficacy · Supplement 2 · standard — Label ↗AP
2018-08-30Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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