ANDA 208813

RISING

FDA Drug Application

Application #208813

Documents

• Letter: 2019-01-22

Application Sponsors

ANDA 208813

RISING

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 60MG BASE

0

TOREMIFENE CITRATE

TOREMIFENE CITRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-12-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208813
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOREMIFENE CITRATE","activeIngredients":"TOREMIFENE CITRATE","strength":"EQ 60MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/04\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208813Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-04
        )

)