ANDA 091247

NOVAST LABS

FDA Drug Application

Application #091247

Application Sponsors

ANDA 091247

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.15MG,N/A;0.02MG,0.01MG

0

PIMTREA

DESOGESTREL; ETHINYL ESTRADIOL

FDA Submissions

	ORIG	1	AP	2013-08-01
LABELING; Labeling	SUPPL	2	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-10-28	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-12-31	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7

TE Codes

001

Prescription

AB

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91247
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIMTREA","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.15MG,N\/A;0.02MG,0.01MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PIMTREA","submission":"DESOGESTREL; ETHINYL ESTRADIOL","actionType":"0.15MG,N\/A;0.02MG,0.01MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)