ANDA 207940

STANDARD CHEM AND PHARM CO LTD

FDA Drug Application

Application #207940

Documents

• Letter: 2021-06-15

Application Sponsors

ANDA 207940

STANDARD CHEM AND PHARM CO LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

EQ 0.5MG BASE

0

FINGOLIMOD

FINGOLIMOD

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-05-11

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

STANDARD CHEM AND PHARM CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207940
            [companyName] => STANDARD CHEM AND PHARM CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FINGOLIMOD","activeIngredients":"FINGOLIMOD","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/11\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-11
        )

)