ANDA 205752

SPECTRUM PHARMS

FDA Drug Application

Application #205752

Application Sponsors

ANDA 205752

SPECTRUM PHARMS

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-12-07

STANDARD

CDER Filings

SPECTRUM PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205752
            [companyName] => SPECTRUM PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"100MG\/VIAL","dosageForm":"POWDER; IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/07\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-07
        )

)