ANDA 207891

SUN PHARM

FDA Drug Application

Application #207891

Documents

• Letter: 2018-11-15

Application Sponsors

ANDA 207891

SUN PHARM

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

20MG

0

OMEPRAZOLE

OMEPRAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-10-12	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-11-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207891
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"20MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/12\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207891Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/16\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-11-16
        )

)