BELOTECA INC FDA Approval ANDA 211831

ANDA 211831

BELOTECA INC

FDA Drug Application

Application #211831

Application Sponsors

ANDA 211831BELOTECA INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION15MG/VIAL0THIOTEPATHIOTEPA

FDA Submissions

UNKNOWN; ORIG1AP2021-12-08STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

BELOTECA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211831
            [companyName] => BELOTECA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIOTEPA","activeIngredients":"THIOTEPA","strength":"15MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/08\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-08
        )

)

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