ANDA 208819

BIONPHARMA INC

FDA Drug Application

Application #208819

Documents

• Letter: 2018-11-15

Application Sponsors

ANDA 208819

BIONPHARMA INC

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	5	AP	2021-11-12	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15

TE Codes

001

Prescription

AB

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208819
            [companyName] => BIONPHARMA INC
            [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":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208819Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-22
        )

)