ANDA 081054

PLIVA

FDA Drug Application

Application #081054

Application Sponsors

ANDA 081054

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

100MG

0

HYDROXYZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

1995-09-25

Submissions Property Types

ORIG

1

Null

0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 81054
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYZINE HYDROCHLORIDE","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROXYZINE HYDROCHLORIDE","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)