ANDA 212001

CUSTOPHARM INC

FDA Drug Application

Application #212001

Application Sponsors

ANDA 212001

CUSTOPHARM INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 500MG BASE/VIAL

0

GANCICLOVIR SODIUM

GANCICLOVIR SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-06-20

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

CUSTOPHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212001
            [companyName] => CUSTOPHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GANCICLOVIR SODIUM","activeIngredients":"GANCICLOVIR SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-20
        )

)