ANDA 212474

TEVA PHARMS USA INC

FDA Drug Application

Application #212474

Documents

• Letter: 2020-08-24

Application Sponsors

ANDA 212474

TEVA PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

EQ 84MG BASE

0

ELIGLUSTAT TARTRATE

ELIGLUSTAT TARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-06-22

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212474
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELIGLUSTAT HEMITARTRATE","activeIngredients":"ELIGLUSTAT HEMITARTRATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/22\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212474Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-22
        )

)