ANDA 216091, held by Msn. Ziprasidone Mesylate.
As of Nov 15, 2026, ANDA 216091 (Ziprasidone Mesylate), held by Msn, was first approved by FDA on Sep 15, 2022, with 0 approved supplements and 0 published complete response letters.
Ziprasidone mesylate for injection intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ziprasidone MesylateEQ 20MG BASE/VIAL · powder;intramuscular | Ziprasidone Mesylate | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
