Ziprasidone Hydrochloride

Treats schizophrenia. ANDA 77565, held by Dr Reddys Labs Inc. Ziprasidone Hydrochloride.

As of Nov 15, 2026, ANDA 77565 (Ziprasidone Hydrochloride), held by Dr Reddys Labs Inc, 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 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 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


Sep 17, 2025	Supplement 26Labeling · Standard review	Approved	None posted
Mar 30, 2023	Supplement 19Labeling · Standard review	Approved	None posted
Mar 30, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Nov 2, 2021	Supplement 14Labeling · Standard review	Approved	None posted
Nov 2, 2021	Supplement 18Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Nov 19, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Apr 13, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Sep 19, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Jul 25, 2013	Supplement 3Labeling · Standard review	Approved	None posted
Mar 22, 2012	Supplement 1Labeling	Approved	None posted
Mar 2, 2012	Original application	Approved	Letter

Identifiers

Application: ANDA 77565
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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