ANDA 210546

LUPIN LTD

FDA Drug Application

Application #210546

Application Sponsors

ANDA 210546

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

2.5MG/ML

0

CLOBAZAM

CLOBAZAM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-12-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-12-03	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210546
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBAZAM","activeIngredients":"CLOBAZAM","strength":"2.5MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/28\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-28
        )

)