ANDA 212977

XIROMED

FDA Drug Application

Application #212977

Application Sponsors

ANDA 212977

XIROMED

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE, DELAYED REL PELLETS;ORAL	10MG	0	OMEPRAZOLE	OMEPRAZOLE
002	CAPSULE, DELAYED REL PELLETS;ORAL	20MG	0	OMEPRAZOLE	OMEPRAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-12-10	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-03-04	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212977
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"10MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"20MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-10
        )

)