ANDA 213553

CHEMO RESEARCH SL

FDA Drug Application

Application #213553

Application Sponsors

ANDA 213553

CHEMO RESEARCH SL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR

50MG/ML

0

FULVESTRANT

FULVESTRANT

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-08-13

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AO

CDER Filings

CHEMO RESEARCH SL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213553
            [companyName] => CHEMO RESEARCH SL
            [docInserts] => ["",""]
            [products] => [{"drugName":"FULVESTRANT","activeIngredients":"FULVESTRANT","strength":"50MG\/ML","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-13
        )

)