FEMPHARM FDA Approval ANDA 212301

ANDA 212301

FEMPHARM

FDA Drug Application

Application #212301

Application Sponsors

ANDA 212301FEMPHARM

Marketing Status

Prescription001

Application Products

001SOLUTION, METERED;TRANSDERMAL30MG/1.5ML ACTUATION0TESTOSTERONETESTOSTERONE

FDA Submissions

UNKNOWN; ORIG1AP2021-01-14STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAT

CDER Filings

FEMPHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212301
            [companyName] => FEMPHARM
            [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":"01\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-14
        )

)

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