ANDA 073594

MAYNE PHARMA

FDA Drug Application

Application #073594

Application Sponsors

ANDA 073594

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.03MG;0.15MG

0

LEVORA 0.15/30-28

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

	ORIG	1	AP	1993-12-13
LABELING; Labeling	SUPPL	2	AP	1996-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-08-16
LABELING; Labeling	SUPPL	24	AP	2014-02-07	STANDARD
LABELING; Labeling	SUPPL	25	AP	2017-07-24	STANDARD
LABELING; Labeling	SUPPL	26	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	28	AP	2022-03-07	STANDARD
LABELING; Labeling	SUPPL	30	AP	2022-03-07	STANDARD
LABELING; Labeling	SUPPL	31	AP	2022-04-29	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	24	Null	15
SUPPL	25	Null	15
SUPPL	26	Null	15
SUPPL	28	Null	15
SUPPL	30	Null	15
SUPPL	31	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73594
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVORA 0.15\/30-28","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.03MG;0.15MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVORA 0.15\/30-28","submission":"ETHINYL ESTRADIOL; LEVONORGESTREL","actionType":"0.03MG;0.15MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)