STRIDES PHARMA FDA Approval ANDA 091356

ANDA 091356

STRIDES PHARMA

FDA Drug Application

Application #091356

Application Sponsors

ANDA 091356STRIDES PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL0.25MCG0CALCITRIOLCALCITRIOL
002CAPSULE;ORAL0.5MCG0CALCITRIOLCALCITRIOL

FDA Submissions

ORIG1AP2014-12-12

Submissions Property Types

ORIG1Null19

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91356
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCITRIOL","activeIngredients":"CALCITRIOL","strength":"0.25MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CALCITRIOL","activeIngredients":"CALCITRIOL","strength":"0.5MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CALCITRIOL","submission":"CALCITRIOL","actionType":"0.25MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CALCITRIOL","submission":"CALCITRIOL","actionType":"0.5MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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