ANDA 211908, held by Gland. Ziprasidone Mesylate.
As of Nov 15, 2026, ANDA 211908 (Ziprasidone Mesylate), held by Gland, was first approved by FDA on Dec 26, 2019, with 4 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 |
|---|---|---|---|
| Dec 26, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ziprasidone MesylateEQ 20MG BASE/VIAL · powder;intramuscular | Ziprasidone Mesylate | Rx |
| Oct 9, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Aug 8, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 2, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 2, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 26, 2019 | Original application | Approved |
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
