ANDA 065221

HIKMA INTL PHARMS

FDA Drug Application

Application #065221

Application Sponsors

ANDA 065221

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

150MG;300MG

0

RIFAMPIN AND ISONIAZID

ISONIAZID; RIFAMPIN

FDA Submissions

ORIG

1

AP

2005-07-29

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65221
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIFAMPIN AND ISONIAZID","activeIngredients":"ISONIAZID; RIFAMPIN","strength":"150MG;300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RIFAMPIN AND ISONIAZID","submission":"ISONIAZID; RIFAMPIN","actionType":"150MG;300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)