RISING FDA Approval ANDA 214475

ANDA 214475

RISING

FDA Drug Application

Application #214475

Application Sponsors

ANDA 214475RISING

Marketing Status

Prescription001

Application Products

001CAPSULE;ORALEQ 400MG BASE0FENOPROFEN CALCIUMFENOPROFEN CALCIUM

FDA Submissions

UNKNOWN; ORIG1AP2022-07-18STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

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
        )

)

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