ANDA 204213

LUPIN LTD

FDA Drug Application

Application #204213

Application Sponsors

ANDA 204213

LUPIN LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	0.0025MG;0.5MG	0	FYAVOLV	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
002	TABLET;ORAL	0.005MG;1MG	0	FYAVOLV	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2021-05-06

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204213
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FYAVOLV","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.0025MG;0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FYAVOLV","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.005MG;1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/10\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-12-10
        )

)