ANDA 202928

MACLEODS PHARMS LTD

FDA Drug Application

Application #202928

Application Sponsors

ANDA 202928

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 75MG BASE

0

CLOPIDOGREL BISULFATE

CLOPIDOGREL BISULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-02-10
LABELING; Labeling	SUPPL	5	AP	2016-05-10	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-06-26	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-06-26	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-06-26	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-06-26	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-06-26	STANDARD
LABELING; Labeling	SUPPL	20	AP	2019-09-20	STANDARD
LABELING; Labeling	SUPPL	26	AP	2021-09-15	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	5	Null	7
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	11	Null	15
SUPPL	14	Null	7
SUPPL	15	Null	7
SUPPL	20	Null	7
SUPPL	26	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202928
            [companyName] => MACLEODS PHARMS LTD
            [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\/10\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/20\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2019","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/10\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-20
        )

)