ANDA 202994

NOVAST LABS

FDA Drug Application

Application #202994

Application Sponsors

ANDA 202994

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.02MG;1MG

0

LARIN 24 FE

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-02-18
LABELING; Labeling	SUPPL	2	AP	2022-03-03	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-03-03	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	15

TE Codes

001

Prescription

AB

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202994
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LARIN 24 FE","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.02MG;1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/18\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-02-18
        )

)