ANDA 077449

AVEVA

FDA Drug Application

Application #077449

Documents

• Review: 2014-01-17
• Other: 2015-06-30

Application Sponsors

ANDA 077449

AVEVA

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	2008-10-20
REMS; REMS	SUPPL	3	AP	2013-02-14
LABELING; Labeling	SUPPL	4	AP	2013-03-07	STANDARD
REMS; REMS	SUPPL	5	AP	2013-04-19
LABELING; Labeling	SUPPL	10	AP	2014-07-23	STANDARD
REMS; REMS	SUPPL	11	AP	2014-08-19
REMS; REMS	SUPPL	15	AP	2015-06-26
	SUPPL	16	AP	2015-09-11
REMS; REMS	SUPPL	18	AP	2016-04-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2016-08-22	UNKNOWN
REMS; REMS	SUPPL	20	AP	2016-09-30
LABELING; Labeling	SUPPL	22	AP	2017-08-10	STANDARD
REMS; REMS	SUPPL	24	AP	2017-05-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2017-08-10	UNKNOWN
REMS; REMS	SUPPL	26	AP	2018-09-18

Submissions Property Types

SUPPL	3	Null	19
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	15	Null	15
SUPPL	16	Null	0
SUPPL	18	Null	7
SUPPL	19	Null	15
SUPPL	20	Null	15
SUPPL	22	Null	31
SUPPL	24	Null	15
SUPPL	25	Null	15
SUPPL	26	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

AVEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77449
            [companyName] => AVEVA
            [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
        )

)