ANDA 203480

GLENMARK PHARMS LTD

FDA Drug Application

Application #203480

Application Sponsors

ANDA 203480

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

625MG

0

COLESEVELAM HYDROCHLORIDE

COLESEVELAM HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-05-18
LABELING; Labeling	SUPPL	2	AP	2022-01-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-01-28	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-01-28	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-01-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	15

TE Codes

001

Prescription

AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203480
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLESEVELAM HYDROCHLORIDE","activeIngredients":"COLESEVELAM HYDROCHLORIDE","strength":"625MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-18
        )

)