Ziprasidone Hydrochloride

Treats schizophrenia. ANDA 204117, held by Aurobindo Pharma. Ziprasidone Hydrochloride.

As of Nov 15, 2026, ANDA 204117 (Ziprasidone Hydrochloride), held by Aurobindo Pharma, was first approved by FDA on Dec 27, 2016, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 27, 2016
Supplements approved: 5
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 6 submissions below

Date	Submission	Status	Documents
Dec 27, 2016	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 6 submissions, including labeling and manufacturing supplements


Mar 18, 2025	Supplement 17Labeling · Standard review	Approved	None posted
Mar 18, 2025	Supplement 18Labeling · Standard review	Approved	None posted
Oct 24, 2023	Supplement 15Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Dec 27, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 204117
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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