Ziprasidone Hydrochloride

Treats schizophrenia. ANDA 204375, held by Macleods Pharms. Ziprasidone Hydrochloride.

As of Nov 15, 2026, ANDA 204375 (Ziprasidone Hydrochloride), held by Macleods Pharms, was first approved by FDA on Feb 17, 2017, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 17, 2017
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ziprasidone capsules are 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. 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Feb 17, 2017	Original application	Approved	None posted

Products

4 strengths and forms


Ziprasidone HydrochlorideEQ 20MG BASE · capsule;oral	Ziprasidone Hydrochloride	Rx
Ziprasidone HydrochlorideEQ 40MG BASE · capsule;oral	Ziprasidone Hydrochloride	Rx
Ziprasidone HydrochlorideEQ 60MG BASE · capsule;oral	Ziprasidone Hydrochloride	Rx
Ziprasidone HydrochlorideEQ 80MG BASE · capsule;oral	Ziprasidone Hydrochloride	Rx

All 5 submissions, including labeling and manufacturing supplements


Jun 7, 2023	Supplement 25Labeling · Standard review	Approved	None posted
Sep 9, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Sep 9, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Sep 9, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Feb 17, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 204375
Drugs@FDA: Overview at FDA
Company: Macleods Pharmaceuticals

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