← FDA DRUG APPROVALS

FDA NDA · NDA212480

SOVALDI

sofosbuvir

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA212480
TYPE
NDA
ORIGINAL APPROVAL
2019-08-28
LATEST ACTION
2024-12-23
ROUTE
ORAL
DOSAGE FORM
PELLETS
MARKETING STATUS
Prescription

Products

SOVALDI · ReferencePrescription
SOFOSBUVIR 150MG/PACKET · PELLETS · ORAL
SOVALDI · ReferencePrescription
SOFOSBUVIR 200MG/PACKET · PELLETS · ORAL

Approval history

2024-12-23Labeling · Supplement 4 · standard — Letter ↗AP
2020-03-05Labeling · Supplement 2 · standard — Letter ↗AP
2019-12-04Labeling · Supplement 3 · standard — Letter ↗AP
2019-09-19Labeling · Supplement 1 · standard — Letter ↗AP
2019-08-28Type 3 - New Dosage Form · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →