ANDA 203860

INVAGEN PHARMS

FDA Drug Application

Application #203860

Application Sponsors

ANDA 203860

INVAGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

800MG

0

SEVELAMER CARBONATE

SEVELAMER CARBONATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2020-04-10	UNKNOWN
LABELING; Labeling	SUPPL	9	AP	2020-12-28	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	6	Null	15
SUPPL	9	Null	7

TE Codes

001

Prescription

AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203860
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEVELAMER CARBONATE","activeIngredients":"SEVELAMER CARBONATE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/28\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/10\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-12-28
        )

)