Geodon

Treats schizophrenia. NDA 20919, held by Viatris. Ziprasidone Mesylate.

As of Nov 14, 2026, NDA 20919 (Geodon), held by Viatris, was first approved by FDA on Jun 21, 2002, with 26 approved supplements and 0 published complete response letters.

First approved: Jun 21, 2002
Review: Standard
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

GEODON 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. GEODON 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Jun 21, 2002	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
GeodonEQ 20MG BASE/VIAL · powder;intramuscular	Ziprasidone Mesylate	RxReference drug

All 27 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 53Labeling · Standard review	Approved	Letter Label
May 18, 2021	Supplement 50Labeling · Standard review	Approved	Label Letter
Oct 29, 2020	Supplement 49Labeling · Standard review	Approved	Label Letter
Jan 23, 2020	Supplement 45Labeling · Standard review	Approved	Letter Label
Nov 5, 2018	Supplement 47Labeling · Standard review	Approved	Letter Label
Feb 23, 2017	Supplement 44Labeling	Approved	Letter Label
Aug 20, 2015	Supplement 41Labeling · Standard review	Approved	Label Letter
Dec 10, 2014	Supplement 40Labeling · Standard review	Approved	Letter Label
Jun 9, 2014	Supplement 39Manufacturing · Standard review	Approved	None posted
Mar 28, 2014	Supplement 36Manufacturing · Standard review	Approved	None posted
Dec 17, 2013	Supplement 35Labeling · Standard review	Approved	Label Letter
Aug 13, 2013	Supplement 32Labeling · Standard review	Approved	Letter Label
Jul 3, 2013	Supplement 27Labeling · Standard review	Approved	Label Letter
Mar 1, 2013	Supplement 30Labeling · Standard review	Approved	Letter Label
Dec 1, 2010	Supplement 25Labeling	Approved	Letter Label
Jul 19, 2009	Supplement 23Labeling	Approved	Letter Label
Dec 19, 2008	Supplement 22Manufacturing	Approved	Letter
Aug 14, 2008	Supplement 21Labeling · Standard review	Approved	Letter
May 16, 2008	Supplement 19Labeling · Standard review	Approved	Letter
Oct 2, 2007	Supplement 16Labeling · Standard review	Approved	Letter Label
May 24, 2007	Supplement 14Labeling · Standard review	Approved	Label Letter
Mar 2, 2007	Supplement 12Labeling · Standard review	Approved	Review Letter Label
Aug 17, 2005	Supplement 6Labeling · Standard review	Approved	Letter Label
Aug 17, 2005	Supplement 5Labeling · Standard review	Approved	Letter Label
Aug 13, 2004	Supplement 3Labeling · Standard review	Approved	Letter
Dec 23, 2003	Supplement 1Labeling · Standard review	Approved	Letter
Jun 21, 2002	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 20919
Drugs@FDA: Overview at FDA
Company: Viatris

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