ANDA 077062

MAYNE PHARMA

FDA Drug Application

Application #077062

Documents

• Other: 2015-06-16

Application Sponsors

ANDA 077062

MAYNE PHARMA

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	FILM, EXTENDED RELEASE;TRANSDERMAL	25MCG/HR	0	FENTANYL-25	FENTANYL
002	FILM, EXTENDED RELEASE;TRANSDERMAL	50MCG/HR	0	FENTANYL-50	FENTANYL
003	FILM, EXTENDED RELEASE;TRANSDERMAL	75MCG/HR	0	FENTANYL-75	FENTANYL
004	FILM, EXTENDED RELEASE;TRANSDERMAL	100MCG/HR	0	FENTANYL-100	FENTANYL

FDA Submissions

	ORIG	1	AP	2007-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2008-01-07
LABELING; Labeling	SUPPL	5	AP	2009-07-07
REMS; REMS	SUPPL	13	AP	2012-07-09
REMS; REMS	SUPPL	18	AP	2012-08-31
LABELING; Labeling	SUPPL	19	AP	2013-04-15
LABELING; Labeling	SUPPL	22	AP	2014-06-24	STANDARD
REMS; REMS	SUPPL	24	AP	2014-08-19
LABELING; Labeling	SUPPL	25	AP	2014-12-21	STANDARD
REMS; REMS	SUPPL	27	AP	2015-06-26
REMS; REMS	SUPPL	29	AP	2016-04-20
REMS; REMS	SUPPL	34	AP	2016-09-30
REMS; REMS	SUPPL	36	AP	2017-05-26
REMS; REMS	SUPPL	38	AP	2018-09-18

Submissions Property Types

SUPPL	3	Null	0
SUPPL	13	Null	7
SUPPL	18	Null	15
SUPPL	19	Null	7
SUPPL	22	Null	15
SUPPL	24	Null	15
SUPPL	25	Null	15
SUPPL	27	Null	31
SUPPL	29	Null	15
SUPPL	34	Null	15
SUPPL	36	Null	7
SUPPL	38	Null	7

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77062
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENTANYL-100","activeIngredients":"FENTANYL","strength":"100MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FENTANYL-25","activeIngredients":"FENTANYL","strength":"25MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FENTANYL-50","activeIngredients":"FENTANYL","strength":"50MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FENTANYL-75","activeIngredients":"FENTANYL","strength":"75MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FENTANYL-100","submission":"FENTANYL","actionType":"100MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FENTANYL-25","submission":"FENTANYL","actionType":"25MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FENTANYL-50","submission":"FENTANYL","actionType":"50MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FENTANYL-75","submission":"FENTANYL","actionType":"75MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)