STRIDES PHARMA FDA Approval ANDA 204195

ANDA 204195

STRIDES PHARMA

FDA Drug Application

Application #204195

Application Sponsors

ANDA 204195STRIDES PHARMA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL325MG;50MG;40MG0BUTALBITAL, ASPIRIN AND CAFFEINEASPIRIN; BUTALBITAL; CAFFEINE

FDA Submissions

UNKNOWN; ORIG1AP2016-09-22

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204195
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ASPIRIN AND CAFFEINE","activeIngredients":"ASPIRIN; BUTALBITAL; CAFFEINE","strength":"325MG;50MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/22\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-09-22
        )

)

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