ANDA 209105

LUPIN LTD

FDA Drug Application

Application #209105

Application Sponsors

ANDA 209105

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

750MG/5ML

0

ATOVAQUONE

ATOVAQUONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-09-11	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-09-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-09-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	31
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209105
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATOVAQUONE","activeIngredients":"ATOVAQUONE","strength":"750MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/11\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/19\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/19\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-19
        )

)