ANDA 091269

DR REDDYS LABS LTD

FDA Drug Application

Application #091269

Application Sponsors

ANDA 091269

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE, DELAYED REL PELLETS;ORAL	15MG	0	LANSOPRAZOLE	LANSOPRAZOLE
002	CAPSULE, DELAYED REL PELLETS;ORAL	30MG	0	LANSOPRAZOLE	LANSOPRAZOLE

FDA Submissions

	ORIG	1	AP	2010-10-15
LABELING; Labeling	SUPPL	2	AP	2012-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2012-05-11
LABELING; Labeling	SUPPL	4	AP	2013-05-02	STANDARD
LABELING; Labeling	SUPPL	5	AP	2013-07-31	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-04-03	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-05-10	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-05-10	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-05-10	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-05-10	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-05-10	STANDARD
LABELING; Labeling	SUPPL	17	AP	2021-10-15	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-10-15	STANDARD
LABELING; Labeling	SUPPL	20	AP	2022-09-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	8	Null	7
SUPPL	12	Null	31
SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	16	Null	31
SUPPL	17	Null	15
SUPPL	18	Null	7
SUPPL	20	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91269
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"30MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LANSOPRAZOLE","submission":"LANSOPRAZOLE","actionType":"15MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LANSOPRAZOLE","submission":"LANSOPRAZOLE","actionType":"30MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)