ANDA 076225

MAYNE PHARMA

FDA Drug Application

Application #076225

Application Sponsors

ANDA 076225

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.35MG

0

ERRIN

NORETHINDRONE

FDA Submissions

	ORIG	1	AP	2002-10-21
LABELING; Labeling	SUPPL	6	AP	2011-06-10
LABELING; Labeling	SUPPL	11	AP	2015-04-02	STANDARD

Submissions Property Types

SUPPL	6	Null	7
SUPPL	11	Null	15

TE Codes

001

Prescription

AB2

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76225
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERRIN","activeIngredients":"NORETHINDRONE","strength":"0.35MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ERRIN","submission":"NORETHINDRONE","actionType":"0.35MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)