← FDA DRUG APPROVALS

FDA NDA · NDA020825

GEODON

ziprasidone

Sponsor: VIATRIS

APPLICATION
NDA020825
TYPE
NDA
ORIGINAL APPROVAL
2001-02-05
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

GEODON · ReferencePrescription
ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
GEODON · ReferencePrescription
ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE · CAPSULE · ORAL
GEODON · ReferencePrescription
ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL
GEODON · ReferencePrescription
ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE · CAPSULE · ORAL

Approval history

2025-01-22Labeling · Supplement 65 · standard — Label ↗AP
2022-01-28Efficacy · Supplement 63 · standard — Letter ↗AP
2021-05-18Labeling · Supplement 62 · standard — Letter ↗AP
2020-10-29Labeling · Supplement 61 · standard — Letter ↗AP
2020-01-23Labeling · Supplement 58 · standard — Letter ↗AP
2018-11-05Labeling · Supplement 59 · standard — Label ↗AP
2017-02-23Labeling · Supplement 56 · 901 required — Label ↗AP
2015-08-20Labeling · Supplement 54 · standard — Letter ↗AP
2015-06-17Manufacturing (CMC) · Supplement 50 · standardAP
2014-12-10Labeling · Supplement 53 · standard — Letter ↗AP
2013-12-17Labeling · Supplement 49 · standard — Letter ↗AP
2013-08-13Labeling · Supplement 47 · standard — Letter ↗AP
2013-07-03Labeling · Supplement 41 · standard — Letter ↗AP
2013-03-01Labeling · Supplement 46 · standard — Label ↗AP
2010-12-01Labeling · Supplement 38 · 901 required — Label ↗AP
2009-11-20Efficacy · Supplement 34 · standard — Label ↗AP
2009-11-12Labeling · Supplement 28 · standardAP
2009-07-19Labeling · Supplement 35 · 901 required — Letter ↗AP
2008-08-14Labeling · Supplement 30 · standard — Letter ↗AP
2008-05-16Labeling · Supplement 27 · standard — Letter ↗AP
2007-10-02Labeling · Supplement 26 · standard — Label ↗AP
2007-05-24Labeling · Supplement 24 · standard — Letter ↗AP
2007-03-02Labeling · Supplement 21 · standard — Letter ↗AP
2005-08-17Labeling · Supplement 17 · standard — Letter ↗AP
2005-08-17Labeling · Supplement 15 · standard — Letter ↗AP
2004-08-19Efficacy · Supplement 9 · standard — Other ↗AP
2004-08-13Labeling · Supplement 12 · standard — Letter ↗AP
2003-12-23Labeling · Supplement 8 · standard — Letter ↗AP
2002-06-25Manufacturing (CMC) · Supplement 5 · standardAP
2002-02-15Labeling · Supplement 6 · standard — Letter ↗AP
2002-01-22Manufacturing (CMC) · Supplement 4 · standardAP
2001-06-07Manufacturing (CMC) · Supplement 1 · standardAP
2001-05-25Manufacturing (CMC) · Supplement 3 · standardAP
2001-05-25Manufacturing (CMC) · Supplement 2 · standardAP
2001-02-05Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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