MICRO LABS FDA Approval ANDA 206152

ANDA 206152

MICRO LABS

FDA Drug Application

Application #206152

Application Sponsors

ANDA 206152MICRO LABS

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL10MG0PIROXICAMPIROXICAM
002CAPSULE;ORAL20MG0PIROXICAMPIROXICAM

FDA Submissions

UNKNOWN; ORIG1AP2017-12-29STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206152
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIROXICAM","activeIngredients":"PIROXICAM","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIROXICAM","activeIngredients":"PIROXICAM","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/29\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-07
        )

)

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