ANDA 206430

CUSTOPHARM INC

FDA Drug Application

Application #206430

Application Sponsors

ANDA 206430

CUSTOPHARM INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVESICAL

40MG/ML

0

VALRUBICIN

VALRUBICIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-19

STANDARD

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AO

CDER Filings

CUSTOPHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206430
            [companyName] => CUSTOPHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALRUBICIN","activeIngredients":"VALRUBICIN","strength":"40MG\/ML","dosageForm":"SOLUTION;INTRAVESICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-19
        )

)