ANDA 209831

TEVA PHARMS USA

FDA Drug Application

Application #209831

Documents

• Letter: 2018-08-20

Application Sponsors

ANDA 209831

TEVA PHARMS USA

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-06-15

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209831
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"","activeIngredients":"","strength":"","dosageForm":"FILM;BUCCAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE; NALOXONE","activeIngredients":"BUPRENORPHINE; NALOXONE","strength":"2.1MG;0.3MG","dosageForm":"FILM;BUCCAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/15\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209831Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-06-15
        )

)