APPLICATION
ANDA215820
TYPE
ANDA
ORIGINAL APPROVAL
2026-05-15
LATEST ACTION
2026-05-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PHYTONADIONEPrescription
PHYTONADIONE 1MG/0.5ML · INJECTABLE · INJECTION
Approval history
2026-05-15UNKNOWN · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.