ANDA 204359

CSPC OUYI

FDA Drug Application

Application #204359

Application Sponsors

ANDA 204359

CSPC OUYI

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 75MG BASE

0

CLOPIDOGREL BISULFATE

CLOPIDOGREL BISULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-02-02
LABELING; Labeling	SUPPL	3	AP	2019-05-28	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-05-28	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-05-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2018-10-29	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2019-05-28	UNKNOWN
LABELING; Labeling	SUPPL	8	AP	2019-05-28	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ADAPTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204359
            [companyName] => ADAPTIS
            [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":"02\/02\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/28\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/28\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/29\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/28\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/28\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/28\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-05-28
        )

)