ANDA 207583

PADDOCK LABS

FDA Drug Application

Application #207583

Application Sponsors

ANDA 207583

PADDOCK LABS

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INTRAMUSCULAR

750MG/3ML (250MG/ML)

0

TESTOSTERONE UNDECANOATE

TESTOSTERONE UNDECANOATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-12-09

STANDARD

Submissions Property Types

ORIG

1

Null

1

CDER Filings

PADDOCK LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207583
            [companyName] => PADDOCK LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE UNDECANOATE","activeIngredients":"TESTOSTERONE UNDECANOATE","strength":"750MG\/3ML (250MG\/ML)","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/09\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-12-09
        )

)