ANDA 203695

ACTAVIS LABS FL INC

FDA Drug Application

Application #203695

Application Sponsors

ANDA 203695

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

800MG

0

METAXALONE

METAXALONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-06-15

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203695
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METAXALONE","activeIngredients":"METAXALONE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/15\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-06-15
        )

)