MICRO LABS FDA Approval ANDA 204355

ANDA 204355

MICRO LABS

FDA Drug Application

Application #204355

Application Sponsors

ANDA 204355MICRO LABS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, DELAYED RELEASE;ORAL50MG;0.2MG0DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOL
002TABLET, DELAYED RELEASE;ORAL75MG;0.2MG0DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOL

FDA Submissions

UNKNOWN; ORIG1AP2021-07-15STANDARD

Submissions Property Types

ORIG1Null19

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204355
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM AND MISOPROSTOL","activeIngredients":"DICLOFENAC SODIUM; MISOPROSTOL","strength":"50MG;0.2MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DICLOFENAC SODIUM AND MISOPROSTOL","activeIngredients":"DICLOFENAC SODIUM; MISOPROSTOL","strength":"75MG;0.2MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/15\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-15
        )

)

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