MYLAN PHARMS INC FDA Approval ANDA 201068

ANDA 201068

MYLAN PHARMS INC

FDA Drug Application

Application #201068

Application Sponsors

ANDA 201068MYLAN PHARMS INC

Marketing Status

Prescription001
Prescription002

Application Products

001UNKNOWNUNKNOWN0SEVELAMER HYDROCHLORIDESEVELAMER HYDROCHLORIDE
002TABLET;ORAL800MG0SEVELAMER HYDROCHLORIDESEVELAMER HYDROCHLORIDE

FDA Submissions

N/A; Not ApplicableORIG1AP2020-12-15

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MYLAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201068
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEVELAMER HYDROCHLORIDE","activeIngredients":"SEVELAMER HYDROCHLORIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SEVELAMER HYDROCHLORIDE","activeIngredients":"SEVELAMER HYDROCHLORIDE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/15\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-15
        )

)

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