ANDA 205630

LUPIN LTD

FDA Drug Application

Application #205630

Application Sponsors

ANDA 205630

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.035MG;0.25MG

0

NORGESTIMATE AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; NORGESTIMATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-10-27	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2019-02-14	UNKNOWN
LABELING; Labeling	SUPPL	8	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	8	Null	31

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205630
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORGESTIMATE AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; NORGESTIMATE","strength":"0.035MG;0.25MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/14\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/14\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-02-14
        )

)