ANDA 206574

ASCENT PHARMS INC

FDA Drug Application

Application #206574

Application Sponsors

ANDA 206574

ASCENT PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

0.5MG

0

DUTASTERIDE

DUTASTERIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-10-21

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ASCENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206574
            [companyName] => ASCENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUTASTERIDE","activeIngredients":"DUTASTERIDE","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/21\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-10-21
        )

)