ANDA 209795

HETERO LABS LTD III

FDA Drug Application

Application #209795

Application Sponsors

ANDA 209795

HETERO LABS LTD III

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	10MG	0	CLOBAZAM	CLOBAZAM
002	TABLET;ORAL	20MG	0	CLOBAZAM	CLOBAZAM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-10-22	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-10-08	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209795
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBAZAM","activeIngredients":"CLOBAZAM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLOBAZAM","activeIngredients":"CLOBAZAM","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/22\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-22
        )

)