ANDA 076258

MYLAN TECHNOLOGIES

FDA Drug Application

Application #076258

Documents

• Review: 2005-07-22
• Other: 2015-06-30
• Letter: 2004-06-24
• Letter: 2005-02-01

Application Sponsors

ANDA 076258

MYLAN TECHNOLOGIES

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007
• Prescription: 008

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
005	FILM, EXTENDED RELEASE;TRANSDERMAL	12.5MCG/HR	0	FENTANYL-12	FENTANYL
006	FILM, EXTENDED RELEASE;TRANSDERMAL	37.5MCG/HR	0	FENTANYL-37	FENTANYL
007	FILM, EXTENDED RELEASE;TRANSDERMAL	62.5MCG/HR	0	FENTANYL-62	FENTANYL
008	FILM, EXTENDED RELEASE;TRANSDERMAL	87.5MCG/HR	0	FENTANYL-87	FENTANYL

FDA Submissions

	ORIG	1	AP	2005-01-28
LABELING; Labeling	SUPPL	2	AP	2005-05-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2007-01-23
LABELING; Labeling	SUPPL	6	AP	2007-01-23
LABELING; Labeling	SUPPL	7	AP	2005-09-06
LABELING; Labeling	SUPPL	10	AP	2008-05-20
LABELING; Labeling	SUPPL	18	AP	2012-07-10
REMS; REMS	SUPPL	19	AP	2012-07-09
LABELING; Labeling	SUPPL	21	AP	2012-07-09
REMS; REMS	SUPPL	22	AP	2013-04-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2015-07-08
LABELING; Labeling	SUPPL	28	AP	2014-06-20	STANDARD
REMS; REMS	SUPPL	30	AP	2014-08-19
REMS; REMS	SUPPL	31	AP	2015-06-26
REMS; REMS	SUPPL	32	AP	2016-04-20
REMS; REMS	SUPPL	33	AP	2016-09-30
REMS; REMS	SUPPL	35	AP	2017-05-26
REMS; REMS	SUPPL	37	AP	2018-09-18

Submissions Property Types

SUPPL	5	Null	0
SUPPL	18	Null	15
SUPPL	19	Null	7
SUPPL	21	Null	7
SUPPL	22	Null	15
SUPPL	27	Null	1
SUPPL	28	Null	15
SUPPL	30	Null	15
SUPPL	31	Null	15
SUPPL	32	Null	15
SUPPL	33	Null	7
SUPPL	35	Null	15
SUPPL	37	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB
007	Prescription	AB
008	Prescription	AB

CDER Filings

MYLAN TECHNOLOGIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76258
            [companyName] => MYLAN TECHNOLOGIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENTANYL-100","activeIngredients":"FENTANYL","strength":"100MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL-12","activeIngredients":"FENTANYL","strength":"12.5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL-25","activeIngredients":"FENTANYL","strength":"25MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL-37","activeIngredients":"FENTANYL","strength":"37.5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL-50","activeIngredients":"FENTANYL","strength":"50MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL-62","activeIngredients":"FENTANYL","strength":"62.5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL-75","activeIngredients":"FENTANYL","strength":"75MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL-87","activeIngredients":"FENTANYL","strength":"87.5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FENTANYL-100","submission":"FENTANYL","actionType":"100MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENTANYL-12","submission":"FENTANYL","actionType":"12.5MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENTANYL-25","submission":"FENTANYL","actionType":"25MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENTANYL-37","submission":"FENTANYL","actionType":"37.5MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENTANYL-50","submission":"FENTANYL","actionType":"50MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENTANYL-62","submission":"FENTANYL","actionType":"62.5MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENTANYL-75","submission":"FENTANYL","actionType":"75MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENTANYL-87","submission":"FENTANYL","actionType":"87.5MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)