ANDA 207626

UMEDICA LABS PVT LTD

FDA Drug Application

Application #207626

Application Sponsors

ANDA 207626

UMEDICA LABS PVT LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 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

2019-04-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

UMEDICA LABS PVT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207626
            [companyName] => UMEDICA LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/09\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-09
        )

)