ANDA 208005

MYLAN

FDA Drug Application

Application #208005

Application Sponsors

ANDA 208005

MYLAN

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

EQ 0.5MG BASE

0

FINGOLIMOD HYDROCHLORIDE

FINGOLIMOD HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-01-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208005
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"FINGOLIMOD HYDROCHLORIDE","activeIngredients":"FINGOLIMOD HYDROCHLORIDE","strength":"EQ 0.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/19\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-19
        )

)