ANDA 072721

MAYNE PHARMA

FDA Drug Application

Application #072721

Application Sponsors

ANDA 072721

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.035MG;1MG

0

ZOVIA 1/35E-28

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

FDA Submissions

	ORIG	1	AP	1991-12-30
LABELING; Labeling	SUPPL	2	AP	1994-09-27
LABELING; Labeling	SUPPL	3	AP	1996-04-10
LABELING; Labeling	SUPPL	4	AP	1997-04-30
LABELING; Labeling	SUPPL	5	AP	2002-09-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-01-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-10-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-07-30
LABELING; Labeling	SUPPL	15	AP	2004-10-20
LABELING; Labeling	SUPPL	36	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	37	AP	2022-04-29	STANDARD

Submissions Property Types

SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	36	Null	7
SUPPL	37	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72721
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOVIA 1\/35E-28","activeIngredients":"ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE","strength":"0.035MG;1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZOVIA 1\/35E-28","submission":"ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE","actionType":"0.035MG;1MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)