ANDA 213977

TEVA PHARMS USA

FDA Drug Application

Application #213977

Application Sponsors

ANDA 213977

TEVA PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

FILM, EXTENDED RELEASE;TRANSDERMAL

0.035MG/24HR;0.15MG/24HR

0

ONSURA

ETHINYL ESTRADIOL; NORELGESTROMIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-08-25

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

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
        )

)