← FDA DRUG APPROVALS

FDA NDA · NDA209195

VOSEVI

sofosbuvir, velpatasvir, and voxilaprevir

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA209195
TYPE
NDA
ORIGINAL APPROVAL
2017-07-18
LATEST ACTION
2019-11-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VOSEVI · ReferencePrescription
SOFOSBUVIR 400MG, VELPATASVIR 100MG, VOXILAPREVIR 100MG · TABLET · ORAL

Approval history

2019-11-15Efficacy · Supplement 3 · standard — Letter ↗AP
2019-09-27Labeling · Supplement 4 · standard — Letter ↗AP
2017-11-09Labeling · Supplement 2 · standard — Letter ↗AP
2017-07-18Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗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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