ANDA 079090

MAYNE PHARMA

FDA Drug Application

Application #079090

Application Sponsors

ANDA 079090

MAYNE PHARMA

Marketing Status

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

Application Products

001	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/24HR	0	CLONIDINE	CLONIDINE
002	FILM, EXTENDED RELEASE;TRANSDERMAL	0.2MG/24HR	0	CLONIDINE	CLONIDINE
003	FILM, EXTENDED RELEASE;TRANSDERMAL	0.3MG/24HR	0	CLONIDINE	CLONIDINE

FDA Submissions

	ORIG	1	AP	2010-08-20
LABELING; Labeling	SUPPL	7	AP	2015-05-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	7	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79090
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLONIDINE","activeIngredients":"CLONIDINE","strength":"0.1MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLONIDINE","activeIngredients":"CLONIDINE","strength":"0.2MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLONIDINE","activeIngredients":"CLONIDINE","strength":"0.3MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLONIDINE","submission":"CLONIDINE","actionType":"0.1MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CLONIDINE","submission":"CLONIDINE","actionType":"0.2MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CLONIDINE","submission":"CLONIDINE","actionType":"0.3MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)