ANDA 202507

XIROMED

FDA Drug Application

Application #202507

Application Sponsors

ANDA 202507

XIROMED

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL-28

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG

0

ELIFEMME

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-12-04
LABELING; Labeling	SUPPL	2	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	5	Null	15

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202507
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELIFEMME","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/04\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/24\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-08-09
        )

)