ANDA 207375

SHANDONG

FDA Drug Application

Application #207375

Application Sponsors

ANDA 207375

SHANDONG

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	5MG	0	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM
002	TABLET;ORAL	10MG	0	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM
003	TABLET;ORAL	20MG	0	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM
004	TABLET;ORAL	40MG	0	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-05-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

SHANDONG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207375
            [companyName] => SHANDONG
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/07\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-07
        )

)