← FDA DRUG APPROVALS

FDA NDA · NDA204671

SOVALDI

sofosbuvir

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA204671
TYPE
NDA
ORIGINAL APPROVAL
2013-12-06
LATEST ACTION
2024-12-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SOVALDI · ReferencePrescription
SOFOSBUVIR 400MG · TABLET · ORAL
SOVALDI · ReferencePrescription
SOFOSBUVIR 200MG · TABLET · ORAL

Approval history

2024-12-23Labeling · Supplement 19 · standard — Letter ↗AP
2020-08-27Labeling · Supplement 18 · standard — Letter ↗AP
2020-03-05Labeling · Supplement 17 · standard — Letter ↗AP
2019-09-19Labeling · Supplement 16 · standard — Letter ↗AP
2019-08-28Efficacy · Supplement 14 · priority — Label ↗AP
2018-10-23Labeling · Supplement 13 · standard — Label ↗AP
2017-11-09Labeling · Supplement 12 · standard — Letter ↗AP
2017-04-07Efficacy · Supplement 6 · priority — Label ↗AP
2017-02-14Labeling · Supplement 7 · 901 required — Label ↗AP
2015-08-19Labeling · Supplement 2 · standard — Letter ↗AP
2015-03-20Labeling · Supplement 4 · standard — Label ↗AP
2014-11-14Labeling · Supplement 1 · standard — Label ↗AP
2013-12-06Type 1 - New Molecular Entity · Original · priority — Pediatric Written Request ↗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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