ANDA 075548

MAYNE PHARMA

FDA Drug Application

Application #075548

Documents

• Review: 2013-05-02
• Letter: 2001-02-05

Application Sponsors

ANDA 075548

MAYNE PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL-28	0.03MG;1.5MG	0	MICROGESTIN FE 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
002	TABLET;ORAL-21	0.03MG;1.5MG	0	MICROGESTIN 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

	ORIG	1	AP	2001-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-07-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-11-07
LABELING; Labeling	SUPPL	4	AP	2003-07-30
LABELING; Labeling	SUPPL	23	AP	2021-08-31	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	23	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75548
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MICROGESTIN 1.5\/30","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.03MG;1.5MG","dosageForm":"TABLET;ORAL-21","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MICROGESTIN FE 1.5\/30","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.03MG;1.5MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MICROGESTIN 1.5\/30","submission":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","actionType":"0.03MG;1.5MG","submissionClassification":"TABLET;ORAL-21","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MICROGESTIN FE 1.5\/30","submission":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","actionType":"0.03MG;1.5MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)