TEVA PHARMS USA FDA Approval ANDA 206388

ANDA 206388

TEVA PHARMS USA

FDA Drug Application

Application #206388

Application Sponsors

ANDA 206388TEVA PHARMS USA

Marketing Status

Prescription001

Application Products

001TABLET;VAGINAL10MCG0ESTRADIOLESTRADIOL

FDA Submissions

UNKNOWN; ORIG1AP2017-07-21STANDARD
LABELING; LabelingSUPPL3AP2021-02-17STANDARD
LABELING; LabelingSUPPL5AP2021-02-17STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null15
SUPPL5Null7

TE Codes

001PrescriptionAB

CDER Filings

TEVA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206388
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"10MCG","dosageForm":"TABLET;VAGINAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/21\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-21
        )

)

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