AMNEAL PHARMS LLC FDA Approval ANDA 211293

ANDA 211293

AMNEAL PHARMS LLC

FDA Drug Application

Application #211293

Application Sponsors

ANDA 211293AMNEAL PHARMS LLC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001FILM, EXTENDED RELEASE;TRANSDERMAL0.025MG/24HR0ESTRADIOLESTRADIOL
002FILM, EXTENDED RELEASE;TRANSDERMAL0.0375MG/24HR0ESTRADIOLESTRADIOL
003FILM, EXTENDED RELEASE;TRANSDERMAL0.05MG/24HR0ESTRADIOLESTRADIOL
004FILM, EXTENDED RELEASE;TRANSDERMAL0.075MG/24HR0ESTRADIOLESTRADIOL
005FILM, EXTENDED RELEASE;TRANSDERMAL0.1MG/24HR0ESTRADIOLESTRADIOL

FDA Submissions

UNKNOWN; ORIG1AP2019-02-05STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB1
002PrescriptionAB1
003PrescriptionAB1
004PrescriptionAB1
005PrescriptionAB1

CDER Filings

AMNEAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211293
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.025MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.0375MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.05MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.075MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.1MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/05\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-05
        )

)

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