NOVAST LABS FDA Approval ANDA 091692

ANDA 091692

NOVAST LABS

FDA Drug Application

Application #091692

Application Sponsors

ANDA 091692NOVAST LABS

Marketing Status

Prescription001

Application Products

001TABLET;ORAL0.02MG;0.09MG0DOLISHALEETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

ORIG1AP2020-10-22

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

NOVAST LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91692
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLISHALE","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.02MG;0.09MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOLISHALE","submission":"ETHINYL ESTRADIOL; LEVONORGESTREL","actionType":"0.02MG;0.09MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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