MICRO LABS FDA Approval ANDA 216872

ANDA 216872

MICRO LABS

FDA Drug Application

Application #216872

Application Sponsors

ANDA 216872MICRO LABS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL0.1MG0MISOPROSTOLMISOPROSTOL
002TABLET;ORAL0.2MG0MISOPROSTOLMISOPROSTOL

FDA Submissions

UNKNOWN; ORIG1AP2022-10-17STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216872
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MISOPROSTOL","activeIngredients":"MISOPROSTOL","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MISOPROSTOL","activeIngredients":"MISOPROSTOL","strength":"0.2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/17\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-17
        )

)

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