ANDA 207994

ZYDUS PHARMS USA INC

FDA Drug Application

Application #207994

Application Sponsors

ANDA 207994

ZYDUS PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

EQ 0.5MG BASE

0

FINGOLIMOD HYDROCHLORIDE

FINGOLIMOD HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-07-11

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207994
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FINGOLIMOD","activeIngredients":"FINGOLIMOD","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/11\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-11
        )

)