ANDA 214463

PATHEON SOFTGELS

FDA Drug Application

Application #214463

Application Sponsors

ANDA 214463

PATHEON SOFTGELS

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

EQ 200MG BASE

0

NAPROXEN SODIUM

NAPROXEN SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-10

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

PATHEON SOFTGELS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214463
            [companyName] => PATHEON SOFTGELS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 200MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/10\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-10
        )

)