ANDA 210714

BELOTECA INC

FDA Drug Application

Application #210714

Application Sponsors

ANDA 210714

BELOTECA INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

1%

0

ISOSULFAN BLUE

ISOSULFAN BLUE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-01-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

BELOTECA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210714
            [companyName] => BELOTECA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSULFAN BLUE","activeIngredients":"ISOSULFAN BLUE","strength":"1%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/16\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-16
        )

)