ANDA 209397

BEIJING

FDA Drug Application

Application #209397

Application Sponsors

ANDA 209397

BEIJING

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

EQ 80MG BASE

0

FLUVASTATIN SODIUM

FLUVASTATIN SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-04-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

BEIJING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209397
            [companyName] => BEIJING
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUVASTATIN SODIUM","activeIngredients":"FLUVASTATIN SODIUM","strength":"EQ 80MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-26
        )

)