ANDA 205564

MACLEODS PHARMS LTD

FDA Drug Application

Application #205564

Application Sponsors

ANDA 205564

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-01-11	STANDARD
LABELING; Labeling	SUPPL	2	AP	2017-09-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-09-18	STANDARD
LABELING; Labeling	SUPPL	4	AP	2017-09-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-09-13	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-09-13	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-09-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	10	Null	7
SUPPL	13	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205564
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOCETIRIZINE DIHYDROCHLORIDE","activeIngredients":"LEVOCETIRIZINE DIHYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/11\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/13\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/13\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/13\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-13
        )

)