ANDA 201686

CADILA

FDA Drug Application

Application #201686

Application Sponsors

ANDA 201686

CADILA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 75MG BASE

0

CLOPIDOGREL BISULFATE

CLOPIDOGREL BISULFATE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-10-10
LABELING; Labeling	SUPPL	2	AP	2019-10-01	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-10-01	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-10-01	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-10-01	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-10-01	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	7

CDER Filings

CADILA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201686
            [companyName] => CADILA
            [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":"10\/10\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/01\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/01\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/01\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/01\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/01\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-01
        )

)