ANDA 207476

SCIEGEN PHARMS INC

FDA Drug Application

Application #207476

Application Sponsors

ANDA 207476

SCIEGEN PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	20MG;1.1GM	0	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE
002	CAPSULE;ORAL	40MG;1.1GM	0	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-12-06	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-02-24	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SCIEGEN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207476
            [companyName] => SCIEGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE AND SODIUM BICARBONATE","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"20MG;1.1GM","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OMEPRAZOLE AND SODIUM BICARBONATE","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"40MG;1.1GM","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/06\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/24\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/24\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-24
        )

)