ANDA 208004

ALKEM LABS LTD

FDA Drug Application

Application #208004

Application Sponsors

ANDA 208004

ALKEM LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

0.5MG

0

FINGOLIMOD

FINGOLIMOD

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-03-23

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208004
            [companyName] => ALKEM LABS LTD
            [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":"12\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-30
        )

)