ANDA 208785

HIKMA

FDA Drug Application

Application #208785

Documents

• Letter: 2018-11-15

Application Sponsors

ANDA 208785

HIKMA

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

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208785
            [companyName] => HIKMA
            [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":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208785Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-22
        )

)