ANDA 078878

DR REDDYS LABS LTD

FDA Drug Application

Application #078878

Documents

• Review: 2013-05-10

Application Sponsors

ANDA 078878

DR REDDYS LABS LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE, DELAYED RELEASE;ORAL

EQ 20MG BASE

0

OMEPRAZOLE MAGNESIUM

OMEPRAZOLE MAGNESIUM

FDA Submissions

	ORIG	1	AP	2009-06-05
LABELING; Labeling	SUPPL	6	AP	2010-11-23
LABELING; Labeling	SUPPL	10	AP	2015-04-06
LABELING; Labeling	SUPPL	11	AP	2012-08-27
LABELING; Labeling	SUPPL	12	AP	2013-10-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2014-02-14	UNKNOWN
LABELING; Labeling	SUPPL	22	AP	2016-06-08	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	6	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	15	Null	15
SUPPL	22	Null	15

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78878
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE MAGNESIUM","activeIngredients":"OMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OMEPRAZOLE MAGNESIUM","submission":"OMEPRAZOLE MAGNESIUM","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)