Geodon

NDA 21483, held by Pfizer Inc. Ziprasidone Hydrochloride.

As of Nov 14, 2026, NDA 21483 (Geodon), held by Pfizer Inc, was first approved by FDA on Mar 29, 2006, with 9 approved supplements and 0 published complete response letters.

First approved: Mar 29, 2006
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Mar 29, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
GeodonEQ 10MG BASE/ML · suspension;oral	Ziprasidone Hydrochloride	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Feb 23, 2017	Supplement 15Labeling	Approved	Letter Label
Aug 20, 2015	Supplement 14Labeling · Standard review	Approved	Label Letter
Dec 10, 2014	Supplement 13Labeling · Standard review	Approved	Label Letter
May 21, 2014	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 13, 2013	Supplement 10Labeling · Standard review	Approved	Letter Label
Jul 3, 2013	Supplement 7Labeling · Standard review	Approved	Letter Label
Mar 1, 2013	Supplement 9Labeling · Standard review	Approved	Letter Label
Dec 1, 2010	Supplement 5Labeling	Approved	Letter Label
Aug 7, 2009	Supplement 3Labeling	Approved	Letter Label
Mar 29, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter

Identifiers

Application: NDA 21483
Drugs@FDA: Overview at FDA
Company: Pfizer

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