ANDA 204600

LUPIN LTD

FDA Drug Application

Application #204600

Application Sponsors

ANDA 204600

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

800MG

0

SEVELAMER CARBONATE

SEVELAMER CARBONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-01-14

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204600
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEVELAMER CARBONATE","activeIngredients":"SEVELAMER CARBONATE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-14
        )

)