MYLAN LABS LTD FDA Approval ANDA 205160

ANDA 205160

MYLAN LABS LTD

FDA Drug Application

Application #205160

Application Sponsors

ANDA 205160MYLAN LABS LTD

Marketing Status

None (Tentative Approval)001

Application Products

001INJECTABLE;INTRAVENOUS, SUBCUTANEOUS3.5MG/VIAL0BORTEZOMIBBORTEZOMIB

FDA Submissions

UNKNOWN; ORIG1TA2018-08-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

MYLAN LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205160
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BORTEZOMIB","activeIngredients":"BORTEZOMIB","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/21\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-08-21
        )

)

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