ANDA 203217

TEVA PHARMS USA

FDA Drug Application

Application #203217

Application Sponsors

ANDA 203217

TEVA PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

35MG

0

RISEDRONATE SODIUM

RISEDRONATE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-05-18

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AB

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203217
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RISEDRONATE SODIUM","activeIngredients":"RISEDRONATE SODIUM","strength":"35MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-05-18
        )

)