ANDA 211368

INGENUS PHARMS LLC

FDA Drug Application

Application #211368

Application Sponsors

ANDA 211368

INGENUS PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

EQ 40MG BASE

0

PANTOPRAZOLE SODIUM

PANTOPRAZOLE SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-03-01	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-12-20	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-06-09	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-06-09	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

INGENUS PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211368
            [companyName] => INGENUS PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 40MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/01\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/20\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-20
        )

)