HARVONI (LEDIPASVIR AND SOFOSBUVIR)
Summary
FDA approved HARVONI (LEDIPASVIR AND SOFOSBUVIR) by GILEAD SCIENCES INC. NDA (New Drug) approval (Labeling) on 2024-12-19. PELLETS, ORAL.
Details
Source
Drug Approval
External ID
NDA212477-6
Action Date
2024-12-19
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
HARVONI (generic: LEDIPASVIR AND SOFOSBUVIR), PELLETS, ORAL. Application: NDA212477
Company
Context & Analysis
GILEAD SCIENCES INC has 11 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
How often does GILEAD SCIENCES INC have FDA actions?
GILEAD SCIENCES INC has 11 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA212477-6" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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