PIFELTRO (DORAVIRINE)
Summary
FDA approved PIFELTRO (DORAVIRINE) by MSD MERCK CO. NDA (New Drug) approval (Labeling) on 2025-10-29. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA210806-13
Action Date
2025-10-29
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
PIFELTRO (generic: DORAVIRINE), TABLET, ORAL. Application: NDA210806
Company
Context & Analysis
MSD MERCK CO has 3 FDA actions in our database.
Frequently Asked Questions
How often does MSD MERCK CO have FDA actions?
MSD MERCK CO has 3 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA210806-13" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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