ANDA 202993

PAR PHARM INC

FDA Drug Application

Application #202993

Application Sponsors

ANDA 202993

PAR PHARM INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

20MG;10MG

0

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

DEXTROMETHORPHAN HYDROBROMIDE;QUINIDINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-12-23

Submissions Property Types

ORIG

1

Null

1

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202993
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE","activeIngredients":"DEXTROMETHORPHAN HYDROBROMIDE;QUINIDINE SULFATE","strength":"20MG;10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/23\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-12-23
        )

)