NDA 019037

JANSSEN PHARMS

FDA Drug Application

Application #019037

Application Sponsors

NDA 019037

JANSSEN PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

1MG/5ML

0

IMODIUM

LOPERAMIDE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1984-07-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-06-02	STANDARD
LABELING; Labeling	SUPPL	3	AP	1987-06-16	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19037
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMODIUM","activeIngredients":"LOPERAMIDE HYDROCHLORIDE","strength":"1MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IMODIUM","submission":"LOPERAMIDE HYDROCHLORIDE","actionType":"1MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)