ANDA 077885

HIKMA INTL PHARMS

FDA Drug Application

Application #077885

Application Sponsors

ANDA 077885

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

12.5MG

0

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

FDA Submissions

ORIG

1

AP

2007-11-26

Submissions Property Types

SUPPL

1

Null

15

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77885
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"12.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"12.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)