STRIDES PHARMA FDA Approval ANDA 205513

ANDA 205513

STRIDES PHARMA

FDA Drug Application

Application #205513

Application Sponsors

ANDA 205513STRIDES PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL250MG0CARISOPRODOLCARISOPRODOL
002TABLET;ORAL350MG0CARISOPRODOLCARISOPRODOL

FDA Submissions

UNKNOWN; ORIG1AP2015-11-12STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAA

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205513
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARISOPRODOL","activeIngredients":"CARISOPRODOL","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARISOPRODOL","activeIngredients":"CARISOPRODOL","strength":"350MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/12\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-11-12
        )

)

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