ANDA 212670

PAR PHARM INC

FDA Drug Application

Application #212670

Application Sponsors

ANDA 212670

PAR PHARM INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

600MG

0

ZILEUTON

ZILEUTON

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-12-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212670
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZILEUTON","activeIngredients":"ZILEUTON","strength":"600MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/16\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-16
        )

)