ANDA 206314

TARO

FDA Drug Application

Application #206314

Application Sponsors

ANDA 206314

TARO

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

600MG/5ML

0

FELBAMATE

FELBAMATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-06-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206314
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"FELBAMATE","activeIngredients":"FELBAMATE","strength":"600MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/16\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-06-16
        )

)