ANDA 210044

AMNEAL

FDA Drug Application

Application #210044

Documents

• Letter: 2019-04-26

Application Sponsors

ANDA 210044

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR

50MG/ML

0

FULVESTRANT

FULVESTRANT

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-03-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AO

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210044
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"FULVESTRANT","activeIngredients":"FULVESTRANT","strength":"50MG\/ML","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210044Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-04
        )

)