ANDA 202975

ACTAVIS LABS FL INC

FDA Drug Application

Application #202975

Application Sponsors

ANDA 202975

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

0.5MG;0.4MG

0

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-11-20

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202975
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE","activeIngredients":"DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE","strength":"0.5MG;0.4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-11-20
        )

)