ANDA 207742

AM REGENT

FDA Drug Application

Application #207742

Application Sponsors

ANDA 207742

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

200MG/ML

0

TESTOSTERONE CYPIONATE

TESTOSTERONE CYPIONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-06-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AO

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207742
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE CYPIONATE","activeIngredients":"TESTOSTERONE CYPIONATE","strength":"200MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/16\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/04\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-04-04
        )

)