ANDA 202562

AM REGENT

FDA Drug Application

Application #202562

Application Sponsors

ANDA 202562

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

0.5MG/VIAL

0

DACTINOMYCIN

DACTINOMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2013-08-23

Submissions Property Types

ORIG

1

Null

15

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202562
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"DACTINOMYCIN","activeIngredients":"DACTINOMYCIN","strength":"0.5MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/23\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-08-23
        )

)