ANDA 211831

BELOTECA INC

FDA Drug Application

Application #211831

Application Sponsors

ANDA 211831

BELOTECA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

15MG/VIAL

0

THIOTEPA

THIOTEPA

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-12-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

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
        )

)