NDA 017994

PHARMACIA AND UPJOHN

FDA Drug Application

Application #017994

Documents

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

Application Sponsors

NDA 017994

PHARMACIA AND UPJOHN

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;TOPICAL

0.05%

0

PSORCON E

DIFLORASONE DIACETATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1978-03-01	STANDARD
LABELING; Labeling	SUPPL	2	AP	1978-11-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1979-12-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1979-05-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1979-07-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1979-07-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1979-07-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1981-01-16	STANDARD
LABELING; Labeling	SUPPL	9	AP	1981-02-18
LABELING; Labeling	SUPPL	11	AP	1981-06-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1981-05-05	STANDARD
LABELING; Labeling	SUPPL	13	AP	1982-08-20
LABELING; Labeling	SUPPL	14	AP	1982-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1983-11-04	STANDARD
LABELING; Labeling	SUPPL	16	AP	1984-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1984-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1986-01-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1988-05-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1997-10-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1999-01-21	STANDARD
LABELING; Labeling	SUPPL	22	AP	2003-05-30	STANDARD
LABELING; Labeling	SUPPL	26	AP	2017-10-25	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	26	Null	15

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17994
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"PSORCON E","activeIngredients":"DIFLORASONE DIACETATE","strength":"0.05%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/25\/2017","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/017994s026lbl.pdf\"}]","notes":""},{"actionDate":"05\/30\/2003","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/17994slr022_psorcon_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PSORCON E","submission":"DIFLORASONE DIACETATE","actionType":"0.05%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2017-10-25
        )

)