ANDA 202789

XIROMED

FDA Drug Application

Application #202789

Application Sponsors

ANDA 202789

XIROMED

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.15MG;0.03MG

0

ISIBLOOM

DESOGESTREL; ETHINYL ESTRADIOL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-08-12
LABELING; Labeling	SUPPL	3	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	7	Null	7

TE Codes

001

Prescription

AB

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202789
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISIBLOOM","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.15MG;0.03MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/12\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/26\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-08-09
        )

)