ANDA 209246

DR REDDYS

FDA Drug Application

Application #209246

Application Sponsors

ANDA 209246

DR REDDYS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR

50MG/ML

0

FULVESTRANT

FULVESTRANT

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-08-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AO

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209246
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FULVESTRANT","activeIngredients":"FULVESTRANT","strength":"50MG\/ML","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/07\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-07
        )

)