ANDA 210316

ALKEM LABS LTD

FDA Drug Application

Application #210316

Application Sponsors

ANDA 210316

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

3.75GM/PACKET

0

COLESEVELAM HYDROCHLORIDE

COLESEVELAM HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-05-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210316
            [companyName] => ALKEM LABS LTD
            [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":"05\/06\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/16\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-16
        )

)