ANDA 202210

MACLEODS PHARMS LTD

FDA Drug Application

Application #202210

Application Sponsors

ANDA 202210

MACLEODS PHARMS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 5MG BASE	0	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE
002	TABLET;ORAL	EQ 10MG BASE	0	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE
003	TABLET;ORAL	EQ 20MG BASE	0	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2012-09-11
LABELING; Labeling	SUPPL	2	AP	2013-05-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	2013-05-21	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-12-13	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-09-09	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-12-10	STANDARD
LABELING; Labeling	SUPPL	16	AP	2021-12-10	STANDARD
LABELING; Labeling	SUPPL	22	AP	2021-12-10	STANDARD
LABELING; Labeling	SUPPL	27	AP	2021-12-10	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	10	Null	15
SUPPL	16	Null	15
SUPPL	22	Null	7
SUPPL	27	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202210
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/11\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/09\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/13\/2014","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/21\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/21\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-09-09
        )

)