ANDA 202754

MACLEODS PHARMS LTD

FDA Drug Application

Application #202754

Application Sponsors

ANDA 202754

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 5MG BASE/5ML

0

ESCITALOPRAM OXALATE

ESCITALOPRAM OXALATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-03-31
LABELING; Labeling	SUPPL	5	AP	2021-09-03	STANDARD
LABELING; Labeling	SUPPL	12	AP	2021-09-21	STANDARD
LABELING; Labeling	SUPPL	16	AP	2022-11-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	7
SUPPL	12	Null	15
SUPPL	16	Null	7

TE Codes

001

Prescription

AA

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202754
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 5MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/31\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-31
        )

)