ANDA 090794

XIROMED

FDA Drug Application

Application #090794

Application Sponsors

ANDA 090794

XIROMED

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.035MG;0.25MG

0

ESTARYLLA

ETHINYL ESTRADIOL; NORGESTIMATE

FDA Submissions

	ORIG	1	AP	2013-01-30
LABELING; Labeling	SUPPL	2	AP	2015-08-31	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-08-31	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-02-03	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	7
SUPPL	11	Null	15

TE Codes

001

Prescription

AB

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90794
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTARYLLA","activeIngredients":"ETHINYL ESTRADIOL; NORGESTIMATE","strength":"0.035MG;0.25MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESTARYLLA","submission":"ETHINYL ESTRADIOL; NORGESTIMATE","actionType":"0.035MG;0.25MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)