ANDA 209970

TEVA PHARMS USA INC

FDA Drug Application

Application #209970

Application Sponsors

ANDA 209970

TEVA PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

375MG

0

MESALAMINE

MESALAMINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-07-11

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209970
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"375MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/11\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-11
        )

)