PATHEON SOFTGELS FDA Approval ANDA 214463

ANDA 214463

PATHEON SOFTGELS

FDA Drug Application

Application #214463

Application Sponsors

ANDA 214463PATHEON SOFTGELS

Marketing Status

Over-the-counter001

Application Products

001CAPSULE;ORALEQ 200MG BASE0NAPROXEN SODIUMNAPROXEN SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2023-01-10STANDARD

Submissions Property Types

ORIG1Null7

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
        )

)

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