ANDA 202807

CATALENT

FDA Drug Application

Application #202807

Application Sponsors

ANDA 202807

CATALENT

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	2019-01-04
LABELING; Labeling	SUPPL	2	AP	2020-04-09	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-04-09	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7

CDER Filings

CATALENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202807
            [companyName] => CATALENT
            [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\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/09\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/09\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-09
        )

)