ANDA 208644

ALKEM LABS LTD

FDA Drug Application

Application #208644

Application Sponsors

ANDA 208644

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

20MG

0

RABEPRAZOLE SODIUM

RABEPRAZOLE SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-04-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-11-19	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-09-14	STANDARD
LABELING; Labeling	SUPPL	14	AP	2022-09-14	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	10	Null	15
SUPPL	14	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208644
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RABEPRAZOLE SODIUM","activeIngredients":"RABEPRAZOLE SODIUM","strength":"20MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/19\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-11-19
        )

)