← FDA DRUG APPROVALS

FDA NDA · NDA210807

DELSTRIGO

doravirine, lamivudine, and tenofovir disoproxil fumarate

Sponsor: MSD MERCK CO

APPLICATION
NDA210807
TYPE
NDA
ORIGINAL APPROVAL
2018-08-30
LATEST ACTION
2025-10-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DELSTRIGO · ReferencePrescription
DORAVIRINE 100MG, LAMIVUDINE 300MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL

Approval history

2025-10-29Labeling · Supplement 17 · standard — Letter ↗AP
2025-06-12Labeling · Supplement 16 · standard — Label ↗AP
2024-11-07Labeling · Supplement 13 · standard — Label ↗AP
2022-01-27Efficacy · Supplement 8 · priority — Label ↗AP
2019-10-10Efficacy · Supplement 3 · standard — Letter ↗AP
2019-09-19Efficacy · Supplement 2 · standard — Letter ↗AP
2018-08-30Type 4 - New Combination · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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