ANDA 091232

XIROMED

FDA Drug Application

Application #091232

Application Sponsors

ANDA 091232

XIROMED

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

0

TRI-LO-ESTARYLLA

ETHINYL ESTRADIOL; NORGESTIMATE

FDA Submissions

	ORIG	1	AP	2015-06-29
LABELING; Labeling	SUPPL	2	AP	2022-02-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91232
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRI-LO-ESTARYLLA","activeIngredients":"ETHINYL ESTRADIOL; NORGESTIMATE","strength":"0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRI-LO-ESTARYLLA","submission":"ETHINYL ESTRADIOL; NORGESTIMATE","actionType":"0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)