TEVA PHARMS USA FDA Approval ANDA 213977

ANDA 213977

TEVA PHARMS USA

FDA Drug Application

Application #213977

Application Sponsors

ANDA 213977TEVA PHARMS USA

Marketing Status

Prescription001

Application Products

001FILM, EXTENDED RELEASE;TRANSDERMAL0.035MG/24HR;0.15MG/24HR0ONSURAETHINYL ESTRADIOL; NORELGESTROMIN

FDA Submissions

UNKNOWN; ORIG1AP2021-08-25STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

TEVA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213977
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONSURA","activeIngredients":"ETHINYL ESTRADIOL; NORELGESTROMIN","strength":"0.035MG\/24HR;0.15MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-25
        )

)

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