NDA 018484

PHARMACIA AND UPJOHN

FDA Drug Application

Application #018484

Documents

• Letter: 2019-07-19
• Label: 2019-10-11

Application Sponsors

NDA 018484

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.5MG/ML

1

PROSTIN VR PEDIATRIC

ALPROSTADIL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1981-10-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-10-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1988-03-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-04-14	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	1987-07-10
LABELING; Labeling	SUPPL	6	AP	1990-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1992-02-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1995-01-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1993-01-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-05-04	PRIORITY
LABELING; Labeling	SUPPL	11	AP	1993-06-26	STANDARD
LABELING; Labeling	SUPPL	12	AP	1994-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-04-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-08-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-05-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-12-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2014-06-09	PRIORITY
LABELING; Labeling	SUPPL	28	AP	2019-07-18	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	15

TE Codes

001

Prescription

AP

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18484
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROSTIN VR PEDIATRIC","activeIngredients":"ALPROSTADIL","strength":"0.5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/18\/2019","submission":"SUPPL-28","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/018484Orig1s028lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PROSTIN VR PEDIATRIC","submission":"ALPROSTADIL","actionType":"0.5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-07-18
        )

)