STRIDES PHARMA FDA Approval ANDA 204649

ANDA 204649

STRIDES PHARMA

FDA Drug Application

Application #204649

Application Sponsors

ANDA 204649STRIDES PHARMA

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL325MG;50MG;40MG;30MG0BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-08

Submissions Property Types

ORIG1Null17

TE Codes

001PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204649
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE","strength":"325MG;50MG;40MG;30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/08\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-08
        )

)

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