ANDA 204237

RUBICON

FDA Drug Application

Application #204237

Application Sponsors

ANDA 204237

RUBICON

Marketing Status

• Prescription: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

20MG

0

RABEPRAZOLE SODIUM

RABEPRAZOLE SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-11-18
LABELING; Labeling	SUPPL	2	AP	2019-11-29	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-11-29	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-11-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	6	Null	15
SUPPL	8	Null	15

TE Codes

001

Prescription

AB

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204237
            [companyName] => RUBICON
            [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":"11\/18\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/29\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/29\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/29\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-29
        )

)