ANDA 211316

IMPAX

FDA Drug Application

Application #211316

Application Sponsors

ANDA 211316

IMPAX

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	FOR SUSPENSION;ORAL	800MG/PACKET	0	SEVELAMER CARBONATE	SEVELAMER CARBONATE
002	FOR SUSPENSION;ORAL	2.4GM/PACKET	0	SEVELAMER CARBONATE	SEVELAMER CARBONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-11-20

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

IMPAX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211316
            [companyName] => IMPAX
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEVELAMER CARBONATE","activeIngredients":"SEVELAMER CARBONATE","strength":"800MG\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SEVELAMER CARBONATE","activeIngredients":"SEVELAMER CARBONATE","strength":"2.4GM\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-20
        )

)