ANDA 205744

SANDOZ INC

FDA Drug Application

Application #205744

Documents

• Letter: 2021-06-15

Application Sponsors

ANDA 205744

SANDOZ INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

UNKNOWN

UNKNOWN

0

DRONEDARONE HYDROCHLORIDE

DRONEDARONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-05-17

STANDARD

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205744
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DRONEDARONE HYDROCHLORIDE","activeIngredients":"DRONEDARONE HYDROCHLORIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/17\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-17
        )

)