APPLICATION
ANDA211908
TYPE
ANDA
ORIGINAL APPROVAL
2019-12-26
LATEST ACTION
2025-10-09
ROUTE
INTRAMUSCULAR
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
ZIPRASIDONE MESYLATEPrescription
ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL · POWDER · INTRAMUSCULAR
Approval history
2025-10-09Labeling · Supplement 5 · standardAP
2023-08-08Labeling · Supplement 4 · standardAP
2021-02-02Labeling · Supplement 1 · standardAP
2021-02-02Labeling · Supplement 2 · 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.