ANDA 216073

DR REDDYS

FDA Drug Application

Application #216073

Application Sponsors

ANDA 216073

DR REDDYS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 200MG BASE

0

SORAFENIB TOSYLATE

SORAFENIB TOSYLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-06-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216073
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SORAFENIB TOSYLATE","activeIngredients":"SORAFENIB TOSYLATE","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-07
        )

)