ANDA 203689

WATSON LABS TEVA

FDA Drug Application

Application #203689

Documents

• Letter: 2017-08-07

Application Sponsors

ANDA 203689

WATSON LABS TEVA

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

2017-07-12

Submissions Property Types

ORIG

1

Null

19

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203689
            [companyName] => WATSON LABS TEVA
            [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":"07\/12\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203689Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-12
        )

)