ANDA 079064

XIROMED

FDA Drug Application

Application #079064

Application Sponsors

ANDA 079064

XIROMED

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.03MG;0.15MG

0

INTROVALE

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

	ORIG	1	AP	2010-09-27
LABELING; Labeling	SUPPL	2	AP	2011-05-18

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79064
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"INTROVALE","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.03MG;0.15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"INTROVALE","submission":"ETHINYL ESTRADIOL; LEVONORGESTREL","actionType":"0.03MG;0.15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)