Ziprasidone Hydrochloride

Treats schizophrenia. ANDA 77561, held by Apotex. Ziprasidone Hydrochloride.

As of Nov 15, 2026, ANDA 77561 (Ziprasidone Hydrochloride), held by Apotex, was first approved by FDA on Mar 2, 2012, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 2, 2012
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia. 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Mar 2, 2012	Original application	Approved	Letter

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 13 submissions, including labeling and manufacturing supplements


Oct 22, 2026	Supplement 25Labeling · Standard review	Approved	None posted
Sep 17, 2025	Supplement 22Labeling · Standard review	Approved	None posted
Sep 17, 2025	Supplement 21Labeling · Standard review	Approved	None posted
Jul 19, 2021	Supplement 19Labeling · Standard review	Approved	None posted
Jul 19, 2021	Supplement 18Labeling · Standard review	Approved	None posted
Jul 19, 2021	Supplement 14Labeling · Standard review	Approved	None posted
Mar 11, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Mar 11, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Feb 18, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Mar 18, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Mar 18, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Sep 18, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Mar 2, 2012	Original application	Approved	Letter

Identifiers

Application: ANDA 77561
Drugs@FDA: Overview at FDA
Company: Apotex

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