STRIDES PHARMA FDA Approval ANDA 203647

ANDA 203647

STRIDES PHARMA

FDA Drug Application

Application #203647

Application Sponsors

ANDA 203647STRIDES PHARMA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL325MG;50MG;40MG0BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-21

Submissions Property Types

ORIG1Null19

TE Codes

001PrescriptionAA

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203647
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","strength":"325MG;50MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-21
        )

)

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