ANDA 200959

TWI PHARMS

FDA Drug Application

Application #200959

Application Sponsors

ANDA 200959

TWI PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

800MG

0

SEVELAMER CARBONATE

SEVELAMER CARBONATE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2018-03-20
LABELING; Labeling	SUPPL	3	AP	2022-04-25	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

TE Codes

001

Prescription

AB

CDER Filings

TWI PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200959
            [companyName] => TWI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEVELAMER CARBONATE","activeIngredients":"SEVELAMER CARBONATE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/20\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-03-20
        )

)