GRANULATION TECH FDA Approval ANDA 212623

ANDA 212623

GRANULATION TECH

FDA Drug Application

Application #212623

Application Sponsors

ANDA 212623GRANULATION TECH

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL500MG0METHOCARBAMOLMETHOCARBAMOL
002TABLET;ORAL750MG0METHOCARBAMOLMETHOCARBAMOL

FDA Submissions

UNKNOWN; ORIG1AP2021-04-30STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA
002PrescriptionAA

CDER Filings

GRANULATION TECH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212623
            [companyName] => GRANULATION TECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/30\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-30
        )

)

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