ANDA 040114

MAYNE PHARMA

FDA Drug Application

Application #040114

Application Sponsors

ANDA 040114

MAYNE PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	1MG	0	ESTRADIOL	ESTRADIOL
002	TABLET;ORAL	2MG	0	ESTRADIOL	ESTRADIOL
003	TABLET;ORAL	0.5MG	0	ESTRADIOL	ESTRADIOL

FDA Submissions

	ORIG	1	AP	1996-03-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-02-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-11-10
LABELING; Labeling	SUPPL	4	AP	1999-10-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-08-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-06-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-07-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-07-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-07-15
LABELING; Labeling	SUPPL	13	AP	2007-02-21
LABELING; Labeling	SUPPL	25	AP	2019-01-31	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	25	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40114
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)