← FDA DRUG APPROVALS

FDA NDA · NDA205834

LEDIPASVIR AND SOFOSBUVIR

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA205834
TYPE
NDA
ORIGINAL APPROVAL
2014-10-10
LATEST ACTION
2024-12-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HARVONI · ReferencePrescription
LEDIPASVIR 90MG, SOFOSBUVIR 400MG · TABLET · ORAL
HARVONI · ReferencePrescription
LEDIPASVIR 45MG, SOFOSBUVIR 200MG · TABLET · ORAL

Approval history

2024-12-19Labeling · Supplement 36 · standard — Letter ↗AP
2020-03-05Labeling · Supplement 32 · standard — Label ↗AP
2019-11-15Efficacy · Supplement 28 · standard — Letter ↗AP
2019-09-19Labeling · Supplement 31 · standard — Letter ↗AP
2019-08-28Efficacy · Supplement 29 · priority — Label ↗AP
2017-11-09Labeling · Supplement 24 · standard — Letter ↗AP
2017-04-07Efficacy · Supplement 17 · priority — Label ↗AP
2017-02-14Labeling · Supplement 18 · 901 required — Label ↗AP
2016-06-22Manufacturing (CMC) · Supplement 12 · priorityAP
2016-06-08Labeling · Supplement 10 · standard — Label ↗AP
2016-02-17Labeling · Supplement 11 · standard — Label ↗AP
2016-02-12Efficacy · Supplement 9 · priority — Label ↗AP
2016-02-12Efficacy · Supplement 7 · priority — Summary Review ↗AP
2016-02-12Efficacy · Supplement 8 · priority — Label ↗AP
2015-11-12Efficacy · Supplement 5 · priority — Label ↗AP
2015-11-12Efficacy · Supplement 3 · priority — Label ↗AP
2015-11-12Efficacy · Supplement 6 · priority — Letter ↗AP
2015-11-12Efficacy · Supplement 4 · priority — Label ↗AP
2015-11-12Efficacy · Supplement 2 · priority — Label ↗AP
2015-03-20Labeling · Supplement 1 · standard — Label ↗AP
2014-10-10Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗AP
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