ANDA 207812

ZYDUS PHARMS

FDA Drug Application

Application #207812

Application Sponsors

ANDA 207812

ZYDUS 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	2017-01-13	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-11-08	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-11-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207812
            [companyName] => ZYDUS 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":"01\/13\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-01-13
        )

)