NDA 018766

PHARMACIA AND UPJOHN

FDA Drug Application

Application #018766

Documents

• Letter: 2006-01-30
• Letter: 2016-05-11
• Label: 2006-01-25
• Label: 2016-05-11
• Letter: 2007-07-05
• Letter: 2010-09-07
• Medication Guide: 2010-08-28
• Label: 2010-08-28

Application Sponsors

NDA 018766

PHARMACIA AND UPJOHN

Marketing Status

• Discontinued: 002
• Discontinued: 003

Application Products

002	TABLET;ORAL	50MG	0	ANSAID	FLURBIPROFEN
003	TABLET;ORAL	100MG	0	ANSAID	FLURBIPROFEN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1988-10-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1989-09-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1991-09-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-04-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-03-25	STANDARD
LABELING; Labeling	SUPPL	10	AP	2001-10-30	STANDARD
LABELING; Labeling	SUPPL	11	AP	2001-10-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-12-13	STANDARD
LABELING; Labeling	SUPPL	13	AP	2006-01-24	STANDARD
LABELING; Labeling	SUPPL	14	AP	2007-06-21	STANDARD
LABELING; Labeling	SUPPL	15	AP	2010-08-13	UNKNOWN
LABELING; Labeling	SUPPL	20	AP	2016-05-09	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	7
SUPPL	20	Null	15

CDER Filings

PHARMACIA AND UPJOHN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18766
            [companyName] => PHARMACIA AND UPJOHN
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2010\/018766s015MedGuide.pdf"]
            [products] => [{"drugName":"ANSAID","activeIngredients":"FLURBIPROFEN","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ANSAID","activeIngredients":"FLURBIPROFEN","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/09\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018766s020lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018766s020lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018766s020lbl.pdf\"}]","notes":""},{"actionDate":"08\/13\/2010","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/018766s015lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2006","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/018766s013lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ANSAID","submission":"FLURBIPROFEN","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ANSAID","submission":"FLURBIPROFEN","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2016-05-09
        )

)