ANDA 079221

XIROMED

FDA Drug Application

Application #079221

Application Sponsors

ANDA 079221

XIROMED

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

3MG;0.02MG

0

LORYNA

DROSPIRENONE; ETHINYL ESTRADIOL

FDA Submissions

	ORIG	1	AP	2011-03-28
LABELING; Labeling	SUPPL	4	AP	2012-09-19	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-04-28	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-04-28	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	11	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	15

TE Codes

001

Prescription

AB

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79221
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORYNA","activeIngredients":"DROSPIRENONE; ETHINYL ESTRADIOL","strength":"3MG;0.02MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LORYNA","submission":"DROSPIRENONE; ETHINYL ESTRADIOL","actionType":"3MG;0.02MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)