ANDA 077154

SPECGX LLC

FDA Drug Application

Application #077154

Documents

• Other: 2015-06-30

Application Sponsors

ANDA 077154

SPECGX LLC

Marketing Status

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

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

FDA Submissions

	ORIG	1	AP	2011-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-06-11
REMS; REMS	SUPPL	3	AP	2012-07-09
LABELING; Labeling	SUPPL	5	AP	2012-07-09
REMS; REMS	SUPPL	6	AP	2013-04-15
LABELING; Labeling	SUPPL	8	AP	2014-06-16	STANDARD
REMS; REMS	SUPPL	10	AP	2014-08-19
REMS; REMS	SUPPL	11	AP	2015-06-26
REMS; REMS	SUPPL	12	AP	2016-04-20
REMS; REMS	SUPPL	16	AP	2016-09-30
REMS; REMS	SUPPL	17	AP	2017-05-26
LABELING; Labeling	SUPPL	19	AP	2020-05-06	STANDARD
REMS; REMS	SUPPL	20	AP	2018-09-18
LABELING; Labeling	SUPPL	21	AP	2020-05-06	STANDARD
LABELING; Labeling	SUPPL	23	AP	2020-05-06	STANDARD
LABELING; Labeling	SUPPL	24	AP	2020-05-06	STANDARD
LABELING; Labeling	SUPPL	25	AP	2020-05-06	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	2	Null	0
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	8	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	16	Null	7
SUPPL	17	Null	7
SUPPL	19	Null	7
SUPPL	20	Null	7
SUPPL	21	Null	15
SUPPL	23	Null	15
SUPPL	24	Null	15
SUPPL	25	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

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77154
            [companyName] => SPECGX LLC
            [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"}]
            [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"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)