ANDA 202962

NOVAST LABS

FDA Drug Application

Application #202962

Application Sponsors

ANDA 202962

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.02MG,0.03MG,0.035MG;1MG,1MG,1MG

0

CHABELINA FE

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-04-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-03-18	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	4	Null	15
SUPPL	6	Null	15

TE Codes

001

Prescription

AB

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202962
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHABELINA FE","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.02MG,0.03MG,0.035MG;1MG,1MG,1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/15\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-15
        )

)