ANDA 083634

NEXGEN PHARMA INC

FDA Drug Application

Application #083634

Application Sponsors

ANDA 083634

NEXGEN PHARMA INC

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

25MG

0

DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

1973-10-12

CDER Filings

NEXGEN PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83634
            [companyName] => NEXGEN PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPHENHYDRAMINE HYDROCHLORIDE","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIPHENHYDRAMINE HYDROCHLORIDE","submission":"DIPHENHYDRAMINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)