STRIDES PHARMA FDA Approval ANDA 207029

ANDA 207029

STRIDES PHARMA

FDA Drug Application

Application #207029

Application Sponsors

ANDA 207029STRIDES PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL5MG0HYDROCORTISONEHYDROCORTISONE
002TABLET;ORAL10MG0HYDROCORTISONEHYDROCORTISONE
003TABLET;ORAL20MG0HYDROCORTISONEHYDROCORTISONE

FDA Submissions

UNKNOWN; ORIG1AP2017-04-27STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207029
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCORTISONE","activeIngredients":"HYDROCORTISONE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCORTISONE","activeIngredients":"HYDROCORTISONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCORTISONE","activeIngredients":"HYDROCORTISONE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-27
        )

)

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