Treats schizophrenia. ANDA 217595, held by Steriscience. Ziprasidone Mesylate.
As of Nov 15, 2026, ANDA 217595 (Ziprasidone Mesylate), held by Steriscience, was first approved by FDA on Sep 3, 2025, with 0 approved supplements and 0 published complete response letters.
Ziprasidone mesylate for injection is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 3, 2025 | 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
