ANDA 206029

LUPIN LTD

FDA Drug Application

Application #206029

Application Sponsors

ANDA 206029

LUPIN LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 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

TA

2016-12-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206029
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PITAVASTATIN CALCIUM","activeIngredients":"PITAVASTATIN CALCIUM","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PITAVASTATIN CALCIUM","activeIngredients":"PITAVASTATIN CALCIUM","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PITAVASTATIN CALCIUM","activeIngredients":"PITAVASTATIN CALCIUM","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/29\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-12-29
        )

)