APPLICATION
ANDA208231
TYPE
ANDA
ORIGINAL APPROVAL
2018-08-31
LATEST ACTION
2023-10-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ARSENIC TRIOXIDEPrescription
ARSENIC TRIOXIDE 1MG/ML · INJECTABLE · INJECTION
Approval history
2023-10-11Labeling · Supplement 2 · standardAP
2023-10-11Labeling · Supplement 3 · 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.