ZYDUS NOVELTECH INC FDA Approval ANDA 206241

ANDA 206241

ZYDUS NOVELTECH INC

FDA Drug Application

Application #206241

Application Sponsors

ANDA 206241ZYDUS NOVELTECH INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001SYSTEM;TRANSDERMAL0.025MG/24HR0ESTRADIOLESTRADIOL
002SYSTEM;TRANSDERMAL0.0375MG/24HR0ESTRADIOLESTRADIOL
003SYSTEM;TRANSDERMAL0.05MG/24HR0ESTRADIOLESTRADIOL
004SYSTEM;TRANSDERMAL0.075MG/24HR0ESTRADIOLESTRADIOL
005SYSTEM;TRANSDERMAL0.1MG/24HR0ESTRADIOLESTRADIOL

FDA Submissions

UNKNOWN; ORIG1AP2022-12-01STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB1
002PrescriptionAB1
003PrescriptionAB1
004PrescriptionAB1
005PrescriptionAB1

CDER Filings

ZYDUS NOVELTECH INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206241
            [companyName] => ZYDUS NOVELTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.025MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.0375MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.05MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.075MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.1MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.025MG\/24HR","submissionClassification":"SYSTEM;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.0375MG\/24HR","submissionClassification":"SYSTEM;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.05MG\/24HR","submissionClassification":"SYSTEM;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.075MG\/24HR","submissionClassification":"SYSTEM;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.1MG\/24HR","submissionClassification":"SYSTEM;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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