ANDA 204786

PAR PHARM INC

FDA Drug Application

Application #204786

Application Sponsors

ANDA 204786

PAR PHARM INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET, ORALLY DISINTEGRATING;ORAL

10MG

0

VARDENAFIL HYDROCHLORIDE

VARDENAFIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-03-17

STANDARD

Submissions Property Types

ORIG

1

Null

17

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204786
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VARDENAFIL HYDROCHLORIDE","activeIngredients":"VARDENAFIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/17\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-17
        )

)