ANDA 203775

RISING

FDA Drug Application

Application #203775

Application Sponsors

ANDA 203775

RISING

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

30MG

0

CEVIMELINE HYDROCHLORIDE

CEVIMELINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-06-04

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203775
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEVIMELINE HYDROCHLORIDE","activeIngredients":"CEVIMELINE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/04\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-06-04
        )

)