ANDA 091352

ZYDUS PHARMS USA INC

FDA Drug Application

Application #091352

Application Sponsors

ANDA 091352

ZYDUS PHARMS USA INC

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

N/A; Not Applicable	ORIG	1	AP	2012-11-19
LABELING; Labeling	SUPPL	3	AP	2014-12-13	STANDARD
LABELING; Labeling	SUPPL	5	AP	2014-12-13	STANDARD
LABELING; Labeling	SUPPL	7	AP	2014-12-13	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-03-02	STANDARD
LABELING; Labeling	SUPPL	9	AP	2018-05-31	STANDARD
LABELING; Labeling	SUPPL	10	AP	2018-05-31	STANDARD
LABELING; Labeling	SUPPL	12	AP	2018-06-07	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-11-27	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-11-27	STANDARD
LABELING; Labeling	SUPPL	21	AP	2022-03-04	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	7
SUPPL	5	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	12	Null	7
SUPPL	18	Null	15
SUPPL	20	Null	15
SUPPL	21	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91352
            [companyName] => ZYDUS PHARMS USA INC
            [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":"OMEPRAZOLE","submission":"OMEPRAZOLE","actionType":"10MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OMEPRAZOLE","submission":"OMEPRAZOLE","actionType":"20MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OMEPRAZOLE","submission":"OMEPRAZOLE","actionType":"40MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)