ANDA 086392

NEXGEN PHARMA INC

FDA Drug Application

Application #086392

Application Sponsors

ANDA 086392

NEXGEN PHARMA INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, CHEWABLE;ORAL

25MG

0

MECLIZINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

1978-09-14

CDER Filings

NEXGEN PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86392
            [companyName] => NEXGEN PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MECLIZINE HYDROCHLORIDE","submission":"MECLIZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)