ANDA 211711

MICRO LABS

FDA Drug Application

Application #211711

Application Sponsors

ANDA 211711

MICRO LABS

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	2019-01-30	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-11-12	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MICRO LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211711
            [companyName] => MICRO LABS
            [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":"01\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-30
        )

)