ANDA 201088

XIROMED

FDA Drug Application

Application #201088

Application Sponsors

ANDA 201088

XIROMED

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.02MG;0.1MG

0

VIENVA

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2015-05-21
LABELING; Labeling	SUPPL	5	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	7

TE Codes

001

Prescription

AB1

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201088
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIENVA","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.02MG;0.1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/21\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-08-09
        )

)