ANDA 201450

HETERO LABS LTD III

FDA Drug Application

Application #201450

Application Sponsors

ANDA 201450

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 10MG BASE/5ML

0

CITALOPRAM HYDROBROMIDE

CITALOPRAM HYDROBROMIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2015-12-15
LABELING; Labeling	SUPPL	3	AP	2020-04-20	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-09-21	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AA

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201450
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 10MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/15\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/20\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-20
        )

)