← FDA DRUG APPROVALS

FDA NDA · NDA208341

EPCLUSA

velpatasvir and sofosbuvir

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA208341
TYPE
NDA
ORIGINAL APPROVAL
2016-06-28
LATEST ACTION
2022-12-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

EPCLUSA · ReferencePrescription
SOFOSBUVIR 400MG, VELPATASVIR 100MG · TABLET · ORAL
EPCLUSA · ReferencePrescription
SOFOSBUVIR 200MG, VELPATASVIR 50MG · TABLET · ORAL

Approval history

2022-12-14Manufacturing (CMC) · Supplement 20 — Letter ↗AP
2022-04-27Efficacy · Supplement 19 · standard — Label ↗AP
2021-06-10Efficacy · Supplement 17 · priority — Label ↗AP
2020-07-14Efficacy · Supplement 15 · standard — Label ↗AP
2020-03-19Efficacy · Supplement 14 · priority — Label ↗AP
2019-11-15Efficacy · Supplement 12 · standard — Letter ↗AP
2019-09-19Labeling · Supplement 13 · standard — Letter ↗AP
2017-11-09Labeling · Supplement 9 · standard — Letter ↗AP
2017-08-31Labeling · Supplement 7 · standard — Label ↗AP
2017-08-01Efficacy · Supplement 1 · standard — Letter ↗AP
2017-02-14Labeling · Supplement 2 · 901 required — Letter ↗AP
2016-06-28Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗AP
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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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