ANDA 201069

MYLAN

FDA Drug Application

Application #201069

Application Sponsors

ANDA 201069

MYLAN

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

800MG

0

SEVELAMER CARBONATE

SEVELAMER CARBONATE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2020-08-05

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201069
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEVELAMER CARBONATE","activeIngredients":"SEVELAMER CARBONATE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/05\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-05
        )

)