ANDA 207653

INVENTIA HEALTHCARE PRIVATE LTD

FDA Drug Application

Application #207653

Application Sponsors

ANDA 207653

INVENTIA HEALTHCARE PRIVATE LTD

Marketing Status

• None (Tentative Approval): 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	UNKNOWN	UNKNOWN	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

TA

2020-08-12

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

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

CDER Filings

INVENTIA HEALTHCARE PRIVATE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207653
            [companyName] => INVENTIA HEALTHCARE PRIVATE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/12\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-12
        )

)