ANDA 209181

APOTEX

FDA Drug Application

Application #209181

Application Sponsors

ANDA 209181

APOTEX

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION, METERED;TRANSDERMAL

30MG/1.5ML ACTUATION

0

TESTOSTERONE

TESTOSTERONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-11-25

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209181
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE","activeIngredients":"TESTOSTERONE","strength":"30MG\/1.5ML ACTUATION","dosageForm":"SOLUTION, METERED;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/25\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-25
        )

)