ANDA 204595

ALVOGEN

FDA Drug Application

Application #204595

Application Sponsors

ANDA 204595

ALVOGEN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	400MG	0	FELBAMATE	FELBAMATE
002	TABLET;ORAL	600MG	0	FELBAMATE	FELBAMATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-01-11

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204595
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"FELBAMATE","activeIngredients":"FELBAMATE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FELBAMATE","activeIngredients":"FELBAMATE","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/11\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-01-11
        )

)