ANDA 212886

IMPAX

FDA Drug Application

Application #212886

Application Sponsors

ANDA 212886

IMPAX

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

3.75GM/PACKET

0

COLESEVELAM HYDROCHLORIDE

COLESEVELAM HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

IMPAX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212886
            [companyName] => IMPAX
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLESEVELAM HYDROCHLORIDE","activeIngredients":"COLESEVELAM HYDROCHLORIDE","strength":"3.75GM\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/18\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-18
        )

)