ANDA 090081

MAYNE PHARMA

FDA Drug Application

Application #090081

Documents

• Letter: 2010-03-22

Application Sponsors

ANDA 090081

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

3MG;0.03MG

0

DROSPIRENONE AND ETHINYL ESTRADIOL

DROSPIRENONE; ETHINYL ESTRADIOL

FDA Submissions

	ORIG	1	AP	2010-09-07
LABELING; Labeling	SUPPL	5	AP	2015-05-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90081
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROSPIRENONE AND ETHINYL ESTRADIOL","activeIngredients":"DROSPIRENONE; ETHINYL ESTRADIOL","strength":"3MG;0.03MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DROSPIRENONE AND ETHINYL ESTRADIOL","submission":"DROSPIRENONE; ETHINYL ESTRADIOL","actionType":"3MG;0.03MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)