ANDA 208003

PRINSTON PHARMA INC

FDA Drug Application

Application #208003

Documents

• Letter: 2017-11-08

Application Sponsors

ANDA 208003

PRINSTON PHARMA 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

2017-10-26

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

PRINSTON PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208003
            [companyName] => PRINSTON PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"Fingolimod Capsules, 0.5 mg","activeIngredients":"FINGOLIMOD","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/26\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208003Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-26
        )

)