NDA 020664

PHARMACIA AND UPJOHN

FDA Drug Application

Application #020664

Documents

• Letter: 2007-02-23
• Letter: 2014-09-10
• Label: 2007-02-21
• Label: 2011-07-18
• Label: 2011-08-12
• Review: 2010-01-05
• Letter: 2006-12-28
• Letter: 2008-01-09
• Letter: 2011-07-21
• Letter: 2011-10-20
• Label: 2006-12-14
• Label: 2007-12-27
• Label: 2014-08-27
• Label: 2019-12-16
• Letter: 2019-12-17

Application Sponsors

NDA 020664

PHARMACIA AND UPJOHN

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

DOSTINEX

CABERGOLINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-05-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	2000-04-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2007-02-09	STANDARD
LABELING; Labeling	SUPPL	8	AP	2006-12-12	STANDARD
LABELING; Labeling	SUPPL	10	AP	2007-12-19	STANDARD
LABELING; Labeling	SUPPL	11	AP	2011-07-18	UNKNOWN
EFFICACY; Efficacy	SUPPL	12	AP	2011-08-11	STANDARD
LABELING; Labeling	SUPPL	13	AP	2014-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2014-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2014-08-29	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-12-13	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	7
SUPPL	12	Null	15
SUPPL	13	Null	6
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	7

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20664
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOSTINEX","activeIngredients":"CABERGOLINE","strength":"0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/13\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020664s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2014","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020664s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2011","submission":"SUPPL-12","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020664s012lbl.pdf\"}]","notes":""},{"actionDate":"07\/18\/2011","submission":"SUPPL-11","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020664s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2007","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020664s010lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2007","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020664s007lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/12\/2006","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020664s008lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DOSTINEX","submission":"CABERGOLINE","actionType":"0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-12-13
        )

)