NDA 021483

PFIZER INC

FDA Drug Application

Application #021483

Documents

• Letter: 2006-04-05
• Letter: 2009-11-24
• Letter: 2013-08-16
• Letter: 2015-08-24
• Label: 2009-09-18
• Label: 2010-12-04
• Label: 2013-08-15
• Label: 2014-12-11
• Label: 2015-09-14
• Other Important Information from FDA: 2006-04-05
• Letter: 2010-12-07
• Letter: 2013-07-05
• Letter: 2013-03-05
• Letter: 2014-12-11
• Label: 2013-07-05
• Label: 2013-03-04
• Review: 2007-06-29
• Label: 2017-02-24
• Letter: 2017-03-02

Application Sponsors

NDA 021483

PFIZER INC

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION;ORAL

EQ 10MG BASE/ML

0

GEODON

ZIPRASIDONE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2006-03-29	STANDARD
LABELING; Labeling	SUPPL	3	AP	2009-08-07	901 REQUIRED
LABELING; Labeling	SUPPL	5	AP	2010-12-01	901 REQUIRED
LABELING; Labeling	SUPPL	7	AP	2013-07-03	STANDARD
LABELING; Labeling	SUPPL	9	AP	2013-03-01	STANDARD
LABELING; Labeling	SUPPL	10	AP	2013-08-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2014-05-21	STANDARD
LABELING; Labeling	SUPPL	13	AP	2014-12-10	STANDARD
LABELING; Labeling	SUPPL	14	AP	2015-08-20	STANDARD
LABELING; Labeling	SUPPL	15	AP	2017-02-23	901 REQUIRED

Submissions Property Types

SUPPL	3	Null	7
SUPPL	5	Null	7
SUPPL	7	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	12	Null	0
SUPPL	13	Null	15
SUPPL	14	Null	6
SUPPL	15	Null	7

CDER Filings

PFIZER INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21483
            [companyName] => PFIZER INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEODON","activeIngredients":"ZIPRASIDONE HYDROCHLORIDE","strength":"EQ 10MG BASE\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/23\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020825s056,020919s044,021483s015lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020825s056,020919s044,021483s015lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2015","submission":"SUPPL-14","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020825s054,020919s041,021483s014lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2015","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020825s054,020919s041,021483s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2014","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020825s053,020919s040,s021483s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/13\/2013","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020825s047,020919s032,021483s010lbl.pdf\"}]","notes":""},{"actionDate":"07\/03\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020825s041,020919s027,021483s007lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2013","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020825s046,020919s030,021483s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2010","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020825s038,020919s025,021483s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2009","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021483s003lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"GEODON","submission":"ZIPRASIDONE HYDROCHLORIDE","actionType":"EQ 10MG BASE\/ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2017-02-23
        )

)