ANDA 209787

LOTUS PHARM CO LTD

FDA Drug Application

Application #209787

Application Sponsors

ANDA 209787

LOTUS PHARM CO LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 2.5MG BASE

0

METHOTREXATE SODIUM

METHOTREXATE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-04-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

LOTUS PHARM CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209787
            [companyName] => LOTUS PHARM CO LTD
            [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":"04\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-23
        )

)