ANDA 205932

ORIENT PHARMA CO LTD

FDA Drug Application

Application #205932

Application Sponsors

ANDA 205932

ORIENT PHARMA CO LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 1MG BASE	0	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM
002	TABLET;ORAL	EQ 2MG BASE	0	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM
003	TABLET;ORAL	EQ 4MG BASE	0	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-02-03

STANDARD

Submissions Property Types

ORIG

1

Null

1

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ORIENT PHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205932
            [companyName] => ORIENT PHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PITAVASTATIN CALCIUM","activeIngredients":"PITAVASTATIN CALCIUM","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PITAVASTATIN CALCIUM","activeIngredients":"PITAVASTATIN CALCIUM","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PITAVASTATIN CALCIUM","activeIngredients":"PITAVASTATIN CALCIUM","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/03\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-02-03
        )

)