ANDA 210569

UPSHER SMITH LABS

FDA Drug Application

Application #210569

Application Sponsors

ANDA 210569

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

2.5MG/ML

0

CLOBAZAM

CLOBAZAM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-10-22	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-12-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001

Prescription

AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210569
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBAZAM","activeIngredients":"CLOBAZAM","strength":"2.5MG\/ML","dosageForm":"SUSPENSION;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
        )

)