ANDA 210040

AMNEAL PHARMS

FDA Drug Application

Application #210040

Application Sponsors

ANDA 210040

AMNEAL PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 2.5MG BASE

0

METHOTREXATE SODIUM

METHOTREXATE SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-12-22	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-10-12	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	8	Null	15

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210040
            [companyName] => AMNEAL PHARMS
            [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":"12\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-22
        )

)