NDA 019260

PHARMACIA AND UPJOHN

FDA Drug Application

Application #019260

Documents

• Label: 2003-04-28
• Letter: 2003-05-29
• Label: 2017-10-26
• Letter: 2017-10-30

Application Sponsors

NDA 019260

PHARMACIA AND UPJOHN

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;TOPICAL

0.05%

1

PSORCON

DIFLORASONE DIACETATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1985-08-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	1986-10-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-03-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-05-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-10-10	STANDARD
LABELING; Labeling	SUPPL	7	AP	2003-04-24	STANDARD
LABELING; Labeling	SUPPL	9	AP	2017-10-25	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	7

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19260
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"PSORCON","activeIngredients":"DIFLORASONE DIACETATE","strength":"0.05%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/25\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019260s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2003","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/019260s007lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PSORCON","submission":"DIFLORASONE DIACETATE","actionType":"0.05%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-10-25
        )

)