ANDA 209422

DR REDDYS

FDA Drug Application

Application #209422

Application Sponsors

ANDA 209422

DR REDDYS

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

60MG/VIAL

0

CARFILZOMIB

CARFILZOMIB

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-09-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209422
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARFILZOMIB","activeIngredients":"CARFILZOMIB","strength":"60MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/09\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-09
        )

)