ANDA 079102

XIROMED

FDA Drug Application

Application #079102

Application Sponsors

ANDA 079102

XIROMED

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.03MG;0.15MG

0

ALTAVERA

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

	ORIG	1	AP	2010-08-03
LABELING; Labeling	SUPPL	2	AP	2011-05-24
LABELING; Labeling	SUPPL	6	AP	2014-02-25	STANDARD
LABELING; Labeling	SUPPL	8	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-03-03	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-03-04	STANDARD
LABELING; Labeling	SUPPL	12	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	6	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	12	Null	7

TE Codes

001

Prescription

AB

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79102
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALTAVERA","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.03MG;0.15MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALTAVERA","submission":"ETHINYL ESTRADIOL; LEVONORGESTREL","actionType":"0.03MG;0.15MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)