ANDA 205588

LUPIN LTD

FDA Drug Application

Application #205588

Application Sponsors

ANDA 205588

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG

0

NORGESTIMATE AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; NORGESTIMATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-04-26	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2019-07-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2021-10-18	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	6	Null	15
SUPPL	8	Null	7
SUPPL	9	Null	15

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205588
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORGESTIMATE AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; NORGESTIMATE","strength":"0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/26\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/03\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/26\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-03
        )

)