ANDA 076273

DR REDDYS LABS INC

FDA Drug Application

Application #076273

Application Sponsors

ANDA 076273

DR REDDYS LABS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 75MG BASE

0

CLOPIDOGREL BISULFATE

CLOPIDOGREL BISULFATE

FDA Submissions

	ORIG	1	AP	2008-01-14
LABELING; Labeling	SUPPL	2	AP	2010-05-18
LABELING; Labeling	SUPPL	3	AP	2010-05-18
LABELING; Labeling	SUPPL	4	AP	2012-04-18
LABELING; Labeling	SUPPL	5	AP	2012-04-18
REMS; REMS	SUPPL	6	AP	2012-04-18
LABELING; Labeling	SUPPL	7	AP	2012-04-18
LABELING; Labeling	SUPPL	8	AP	2012-04-18
LABELING; Labeling	SUPPL	11	AP	2014-06-12	STANDARD
LABELING; Labeling	SUPPL	12	AP	2014-06-12	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-05-11	STANDARD
LABELING; Labeling	SUPPL	15	AP	2016-05-11	STANDARD
LABELING; Labeling	SUPPL	16	AP	2016-05-11	STANDARD
LABELING; Labeling	SUPPL	18	AP	2019-08-20	STANDARD
LABELING; Labeling	SUPPL	20	AP	2019-08-02	STANDARD
LABELING; Labeling	SUPPL	21	AP	2019-08-02	STANDARD
LABELING; Labeling	SUPPL	23	AP	2019-08-02	STANDARD
LABELING; Labeling	SUPPL	24	AP	2019-08-02	STANDARD
LABELING; Labeling	SUPPL	25	AP	2019-08-02	STANDARD
LABELING; Labeling	SUPPL	29	AP	2021-12-21	STANDARD
LABELING; Labeling	SUPPL	33	AP	2023-01-09	STANDARD

Submissions Property Types

SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	14	Null	31
SUPPL	15	Null	15
SUPPL	16	Null	7
SUPPL	18	Null	15
SUPPL	20	Null	15
SUPPL	21	Null	7
SUPPL	23	Null	15
SUPPL	24	Null	7
SUPPL	25	Null	7
SUPPL	29	Null	15
SUPPL	33	Null	7

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76273
            [companyName] => DR REDDYS LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOPIDOGREL BISULFATE","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLOPIDOGREL BISULFATE","submission":"CLOPIDOGREL BISULFATE","actionType":"EQ 75MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)