ANDA 214475

RISING

FDA Drug Application

Application #214475

Documents

• Letter: 2022-08-30

Application Sponsors

ANDA 214475

RISING

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

EQ 400MG BASE

0

FENOPROFEN CALCIUM

FENOPROFEN CALCIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-07-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214475
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOPROFEN CALCIUM","activeIngredients":"FENOPROFEN CALCIUM","strength":"EQ 400MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-18
        )

)