ANDA 202221

HETERO LABS LTD III

FDA Drug Application

Application #202221

Application Sponsors

ANDA 202221

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 5MG BASE/5ML

0

ESCITALOPRAM OXALATE

ESCITALOPRAM OXALATE

FDA Submissions

	ORIG	1	AP	2012-06-12
LABELING; Labeling	SUPPL	2	AP	2021-08-03	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2021-08-03	UNKNOWN
LABELING; Labeling	SUPPL	6	AP	2021-09-21	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-11-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	9	Null	7

TE Codes

001

Prescription

AA

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202221
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 5MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/12\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/02\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-02-02
        )

)