ANDA 208043

ACTAVIS LABS FL INC

FDA Drug Application

Application #208043

Documents

• Letter: 2022-12-20

Application Sponsors

ANDA 208043

ACTAVIS LABS FL INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET, EXTENDED RELEASE; ORAL

8MG/90MG

0

NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE

NALTREXONE HYDROCHLORIDE;BUPROPION HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-11-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208043
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE","activeIngredients":"NALTREXONE HYDROCHLORIDE;BUPROPION HYDROCHLORIDE","strength":"8MG\/90MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/29\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-29
        )

)