ANDA 070118

MORTON GROVE

FDA Drug Application

Application #070118

Application Sponsors

ANDA 070118

MORTON GROVE

Marketing Status

• Discontinued: 001

Application Products

001

SYRUP;ORAL

12.5MG/5ML

0

DIPHEN

DIPHENHYDRAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1993-06-28
LABELING; Labeling	SUPPL	7	AP	1991-09-18
LABELING; Labeling	SUPPL	8	AP	1992-02-13

CDER Filings

MORTON GROVE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70118
            [companyName] => MORTON GROVE
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPHEN","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE","strength":"12.5MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIPHEN","submission":"DIPHENHYDRAMINE HYDROCHLORIDE","actionType":"12.5MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)