ANDA 200541

LUPIN PHARMS

FDA Drug Application

Application #200541

Application Sponsors

ANDA 200541

LUPIN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

0

NORGESTIMATE AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; NORGESTIMATE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-06-25
LABELING; Labeling	SUPPL	5	AP	2019-01-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2019-01-28	UNKNOWN
LABELING; Labeling	SUPPL	12	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	31
SUPPL	8	Null	7
SUPPL	12	Null	7

TE Codes

001

Prescription

AB

CDER Filings

LUPIN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200541
            [companyName] => LUPIN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORGESTIMATE AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; NORGESTIMATE","strength":"0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/25\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/28\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/28\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/26\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-01-28
        )

)