ANDA 207905

APOTEX

FDA Drug Application

Application #207905

Application Sponsors

ANDA 207905

APOTEX

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

NALTREXONE HYDROCHLORIDE

NALTREXONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-07-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

CHARTWELL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207905
            [companyName] => CHARTWELL
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALTREXONE HYDROCHLORIDE","activeIngredients":"NALTREXONE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/21\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-21
        )

)