ANDA 078133

SUN PHARM INDUSTRIES

FDA Drug Application

Application #078133

Application Sponsors

ANDA 078133

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 75MG BASE

0

CLOPIDOGREL BISULFATE

CLOPIDOGREL BISULFATE

FDA Submissions

	ORIG	1	AP	2013-06-10
LABELING; Labeling	SUPPL	2	AP	2020-05-19	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-05-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78133
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOPIDOGREL BISULFATE","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLOPIDOGREL BISULFATE","submission":"CLOPIDOGREL BISULFATE","actionType":"EQ 75MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)