ANDA 207113

ACTAVIS LABS FL INC

FDA Drug Application

Application #207113

Documents

• Letter: 2016-10-03

Application Sponsors

ANDA 207113

ACTAVIS LABS FL INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

325MG; 7.5MG

0

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-09-27

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207113
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"325MG; 7.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/27\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207113Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-09-27
        )

)