← FDA DRUG APPROVALS

FDA NDA · NDA214187

EPCLUSA

velpatasvir and sofosbuvir

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA214187
TYPE
NDA
ORIGINAL APPROVAL
2021-06-10
LATEST ACTION
2022-04-27
ROUTE
ORAL
DOSAGE FORM
PELLETS
MARKETING STATUS
Prescription

Products

EPCLUSA · ReferencePrescription
SOFOSBUVIR 200MG, VELPATASVIR 50MG/PACKET · PELLETS · ORAL
EPCLUSA · ReferencePrescription
SOFOSBUVIR 150MG, VELPATASVIR 37.5MG/PACKET · PELLETS · ORAL

Approval history

2022-04-27Efficacy · Supplement 1 · standard — Label ↗AP
2021-06-10Type 3 - New Dosage Form · Original · priority — Label ↗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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