ANDA 091023

DR REDDYS LABS LTD

FDA Drug Application

Application #091023

Documents

• Letter: 2012-05-18

Application Sponsors

ANDA 091023

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 300MG BASE

0

CLOPIDOGREL BISULFATE

CLOPIDOGREL BISULFATE

FDA Submissions

	ORIG	1	AP	2012-05-17
LABELING; Labeling	SUPPL	3	AP	2015-04-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2015-07-28	UNKNOWN
LABELING; Labeling	SUPPL	5	AP	2015-04-17	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-04-17	STANDARD
LABELING; Labeling	SUPPL	7	AP	2016-05-11	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-08-07	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-08-07	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-08-07	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-08-07	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-08-07	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-08-07	STANDARD
LABELING; Labeling	SUPPL	17	AP	2022-09-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	17	Null	7

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91023
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOPIDOGREL BISULFATE","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLOPIDOGREL BISULFATE","submission":"CLOPIDOGREL BISULFATE","actionType":"EQ 300MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)