NDA 020398

JANSSEN PHARMS

FDA Drug Application

Application #020398

Documents

• Review: 2000-03-06
• Review: 2000-03-06

Application Sponsors

NDA 020398

JANSSEN PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION;ORAL

EQ 1MG BASE/ML

0

PROPULSID

CISAPRIDE MONOHYDRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1995-09-15	STANDARD
LABELING; Labeling	SUPPL	2	AP	1995-12-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-01-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-10-28	STANDARD
LABELING; Labeling	SUPPL	8	AP	1997-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-09-22	STANDARD
LABELING; Labeling	SUPPL	14	AP	1998-07-31	STANDARD
LABELING; Labeling	SUPPL	15	AP	1998-08-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1999-01-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1999-02-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1999-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1999-11-10	STANDARD
LABELING; Labeling	SUPPL	20	AP	2000-03-06	STANDARD
LABELING; Labeling	SUPPL	22	AP	2000-03-06	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20398
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPULSID","activeIngredients":"CISAPRIDE MONOHYDRATE","strength":"EQ 1MG BASE\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPULSID","submission":"CISAPRIDE MONOHYDRATE","actionType":"EQ 1MG BASE\/ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)