ANDA 203481

BRECKENRIDGE

FDA Drug Application

Application #203481

Application Sponsors

ANDA 203481

BRECKENRIDGE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE, DELAYED REL PELLETS;ORAL	10MG	0	OMEPRAZOLE	OMEPRAZOLE
002	CAPSULE, DELAYED REL PELLETS;ORAL	20MG	0	OMEPRAZOLE	OMEPRAZOLE
003	CAPSULE, DELAYED REL PELLETS;ORAL	40MG	0	OMEPRAZOLE	OMEPRAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-07-03
LABELING; Labeling	SUPPL	5	AP	2020-12-11	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-03-04	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203481
            [companyName] => BRECKENRIDGE
            [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"},{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"40MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/03\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/11\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/07\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-12-11
        )

)