ANDA 211730

APOTEX

FDA Drug Application

Application #211730

Application Sponsors

ANDA 211730

APOTEX

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR

50MG/ML

0

FULVESTRANT

FULVESTRANT

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-06-11

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AO

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211730
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"FULVESTRANT","activeIngredients":"FULVESTRANT","strength":"50MG\/ML","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-11
        )

)