ANDA 209234

ALKEM LABS LTD

FDA Drug Application

Application #209234

Application Sponsors

ANDA 209234

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

10MG

0

EZETIMIBE

EZETIMIBE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-12-21	STANDARD
LABELING; Labeling	SUPPL	12	AP	2022-12-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	12	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209234
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EZETIMIBE","activeIngredients":"EZETIMIBE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/21\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/21\/2018","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-05-21
        )

)