MICRO LABS FDA Approval ANDA 207403

ANDA 207403

MICRO LABS

FDA Drug Application

Application #207403

Application Sponsors

ANDA 207403MICRO LABS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL75MG0BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE
002TABLET;ORAL100MG0BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-04-17STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207403
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-17
        )

)

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