STRIDES PHARMA FDA Approval ANDA 090912

ANDA 090912

STRIDES PHARMA

FDA Drug Application

Application #090912

Application Sponsors

ANDA 090912STRIDES PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL25MG0ACARBOSEACARBOSE
002TABLET;ORAL50MG0ACARBOSEACARBOSE
003TABLET;ORAL100MG0ACARBOSEACARBOSE

FDA Submissions

N/A; Not ApplicableORIG1AP2011-07-27

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90912
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACARBOSE","activeIngredients":"ACARBOSE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"ACARBOSE","activeIngredients":"ACARBOSE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ACARBOSE","activeIngredients":"ACARBOSE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACARBOSE","submission":"ACARBOSE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ACARBOSE","submission":"ACARBOSE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ACARBOSE","submission":"ACARBOSE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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