DR REDDYS FDA Approval ANDA 209246

ANDA 209246

DR REDDYS

FDA Drug Application

Application #209246

Application Sponsors

ANDA 209246DR REDDYS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAMUSCULAR50MG/ML0FULVESTRANTFULVESTRANT

FDA Submissions

UNKNOWN; ORIG1AP2020-08-07STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAO

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
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.