APPLICATION
ANDA211661
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-30
LATEST ACTION
2023-06-23
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
VORICONAZOLEPrescription
VORICONAZOLE 200MG/VIAL · POWDER · INTRAVENOUS
Approval history
2023-06-23Labeling · Supplement 10 · standardAP
2021-08-10Labeling · Supplement 9 · standardAP
2021-08-10Labeling · Supplement 3 · standardAP
2021-08-10Labeling · Supplement 1 · standardAP
2021-08-10Labeling · Supplement 8 · standardAP
2018-11-30UNKNOWN · 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.