ANDA 202254

MACLEODS PHARMS LTD

FDA Drug Application

Application #202254

Application Sponsors

ANDA 202254

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	75MG	0	IRBESARTAN	IRBESARTAN
002	TABLET;ORAL	150MG	0	IRBESARTAN	IRBESARTAN
003	TABLET;ORAL	300MG	0	IRBESARTAN	IRBESARTAN

FDA Submissions

	ORIG	1	AP	2012-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2013-03-11	UNKNOWN
LABELING; Labeling	SUPPL	6	AP	2015-12-28	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-08-09	STANDARD
LABELING; Labeling	SUPPL	21	AP	2018-10-24	STANDARD
LABELING; Labeling	SUPPL	34	AP	2021-05-06	STANDARD
LABELING; Labeling	SUPPL	37	AP	2021-12-08	STANDARD
LABELING; Labeling	SUPPL	41	AP	2021-12-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	6	Null	7
SUPPL	11	Null	15
SUPPL	21	Null	7
SUPPL	34	Null	15
SUPPL	37	Null	7
SUPPL	41	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202254
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/03\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/24\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/09\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/28\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/11\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-10-24
        )

)