ANDA 207939

HEC PHARM CO LTD

FDA Drug Application

Application #207939

Application Sponsors

ANDA 207939

HEC PHARM CO LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

EQ 0.5MG BASE

0

FINGOLIMOD HYDROCHLORIDE

FINGOLIMOD HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-12-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

HEC PHARM CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207939
            [companyName] => HEC PHARM CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FINGOLIMOD HYDROCHLORIDE","activeIngredients":"FINGOLIMOD HYDROCHLORIDE","strength":"EQ 0.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/25\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-25
        )

)