STRIDES PHARMA FDA Approval ANDA 204262

ANDA 204262

STRIDES PHARMA

FDA Drug Application

Application #204262

Application Sponsors

ANDA 204262STRIDES PHARMA

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL0.5MG0DUTASTERIDEDUTASTERIDE

FDA Submissions

UNKNOWN; ORIG1AP2015-11-20
LABELING; LabelingSUPPL9AP2021-11-16STANDARD

Submissions Property Types

ORIG1Null15
SUPPL9Null7

TE Codes

001PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204262
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUTASTERIDE","activeIngredients":"DUTASTERIDE","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-11-20
        )

)

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