ANDA 078490

DR REDDYS LABS LTD

FDA Drug Application

Application #078490

Application Sponsors

ANDA 078490

DR REDDYS LABS LTD

Marketing Status

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

Application Products

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

FDA Submissions

	ORIG	1	AP	2009-04-17
LABELING; Labeling	SUPPL	2	AP	2012-03-14
LABELING; Labeling	SUPPL	4	AP	2015-03-16	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-03-16	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-03-16	STANDARD
LABELING; Labeling	SUPPL	10	AP	2018-05-31	STANDARD
LABELING; Labeling	SUPPL	12	AP	2018-05-31	STANDARD
LABELING; Labeling	SUPPL	14	AP	2018-06-07	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-12-09	STANDARD
LABELING; Labeling	SUPPL	18	AP	2022-03-04	STANDARD

Submissions Property Types

SUPPL	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	10	Null	15
SUPPL	12	Null	15
SUPPL	14	Null	7
SUPPL	16	Null	7
SUPPL	18	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78490
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"40MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"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":"OMEPRAZOLE","submission":"OMEPRAZOLE","actionType":"40MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"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"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)