FDA NDA · NDA021483

GEODON

Sponsor: PFIZER INC

APPLICATION

NDA021483

TYPE

NDA

ORIGINAL APPROVAL

2006-03-29

LATEST ACTION

2017-02-23

ROUTE

ORAL

DOSAGE FORM

SUSPENSION

MARKETING STATUS

Discontinued

Products

GEODONDiscontinued

ZIPRASIDONE HYDROCHLORIDE EQ 10MG BASE/ML · SUSPENSION · ORAL

2017-02-23Labeling · Supplement 15 · 901 required — Label ↗AP

2015-08-20Labeling · Supplement 14 · standard — Letter ↗AP

2014-12-10Labeling · Supplement 13 · standard — Label ↗AP

2014-05-21Manufacturing (CMC) · Supplement 12 · standardAP

2013-08-13Labeling · Supplement 10 · standard — Letter ↗AP

2013-07-03Labeling · Supplement 7 · standard — Letter ↗AP

2013-03-01Labeling · Supplement 9 · standard — Label ↗AP

2010-12-01Labeling · Supplement 5 · 901 required — Label ↗AP

2009-08-07Labeling · Supplement 3 · 901 required — Letter ↗AP

2006-03-29Type 3 - New Dosage Form · Original · standard — Review ↗AP

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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