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FDA NDA · NDA212477

HARVONI

ledipasvir and sofosbuvir

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA212477
TYPE
NDA
ORIGINAL APPROVAL
2019-08-28
LATEST ACTION
2024-12-19
ROUTE
ORAL
DOSAGE FORM
PELLETS
MARKETING STATUS
Prescription

Products

HARVONI · ReferencePrescription
LEDIPASVIR 33.75MG, SOFOSBUVIR 150MG/PACKET · PELLETS · ORAL
HARVONI · ReferencePrescription
LEDIPASVIR 45MG, SOFOSBUVIR 200MG/PACKET · PELLETS · ORAL

Approval history

2024-12-19Labeling · Supplement 6 · standard — Letter ↗AP
2020-03-05Labeling · Supplement 3 · standard — Label ↗AP
2019-12-04Labeling · Supplement 4 · standard — Letter ↗AP
2019-11-15Efficacy · Supplement 2 · 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 ↗

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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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