NDA 019259

PHARMACIA AND UPJOHN

FDA Drug Application

Application #019259

Documents

• Letter: 2003-06-08
• Label: 2003-06-08
• Label: 2017-10-26
• Letter: 2017-10-30

Application Sponsors

NDA 019259

PHARMACIA AND UPJOHN

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;TOPICAL

0.05%

0

FLORONE E

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	1986-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1993-03-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-05-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-10-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-01-21	STANDARD
LABELING; Labeling	SUPPL	9	AP	2003-05-29	STANDARD
LABELING; Labeling	SUPPL	12	AP	2017-10-25	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	12	Null	6

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19259
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLORONE E","activeIngredients":"DIFLORASONE DIACETATE","strength":"0.05%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/25\/2017","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019259s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2003","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/19259slr009_psorcon_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FLORONE E","submission":"DIFLORASONE DIACETATE","actionType":"0.05%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2017-10-25
        )

)