TEVA PHARMS USA INC FDA Approval ANDA 204305

ANDA 204305

TEVA PHARMS USA INC

FDA Drug Application

Application #204305

Application Sponsors

ANDA 204305TEVA PHARMS USA INC

Marketing Status

Prescription001

Application Products

001RING;VAGINAL0.015MG/24HR;0.12MG/24HR0ETHINYL ESTRADIOL; ETONOGESTRELETHINYL ESTRADIOL; ETONOGESTREL

FDA Submissions

UNKNOWN; ORIG1AP2021-01-13STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

TEVA PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204305
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETHINYL ESTRADIOL; ETONOGESTREL","activeIngredients":"ETHINYL ESTRADIOL; ETONOGESTREL","strength":"0.015MG\/24HR;0.12MG\/24HR","dosageForm":"RING;VAGINAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-13
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.