ANDA 210454

EUGIA PHARMA

FDA Drug Application

Application #210454

Application Sponsors

ANDA 210454

EUGIA PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 2.5MG BASE

0

METHOTREXATE SODIUM

METHOTREXATE SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-01-30	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-08-26	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

EUGIA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210454
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHOTREXATE SODIUM","activeIngredients":"METHOTREXATE SODIUM","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/26\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/26\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-26
        )

)