ANDA 091692

NOVAST LABS

FDA Drug Application

Application #091692

Application Sponsors

ANDA 091692

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.02MG;0.09MG

0

DOLISHALE

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

	ORIG	1	AP	2020-10-22
LABELING; Labeling	SUPPL	3	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7

TE Codes

001

Prescription

AB

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91692
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLISHALE","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.02MG;0.09MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOLISHALE","submission":"ETHINYL ESTRADIOL; LEVONORGESTREL","actionType":"0.02MG;0.09MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)