ANDA 078907

SPECGX LLC

FDA Drug Application

Application #078907

Documents

• Letter: 2009-11-05
• Medication Guide: 2009-11-04
• Other: 2012-02-03

Application Sponsors

ANDA 078907

SPECGX LLC

Marketing Status

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

Application Products

001	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.2MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE
002	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.4MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE
003	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.6MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE
004	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.8MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE
005	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 1.2MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE
006	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 1.6MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE

FDA Submissions

	ORIG	1	AP	2009-10-30
REMS; REMS	SUPPL	7	AP	2012-01-04
LABELING; Labeling	SUPPL	8	AP	2012-01-04
LABELING; Labeling	SUPPL	9	AP	2012-06-08
REMS; REMS	SUPPL	11	AP	2013-11-07
REMS; REMS	SUPPL	12	AP	2014-12-24
LABELING; Labeling	SUPPL	15	AP	2017-04-24	STANDARD
REMS; REMS	SUPPL	16	AP	2017-09-07
REMS; REMS	SUPPL	17	AP	2020-12-23
REMS; REMS	SUPPL	22	AP	2021-12-03
REMS; REMS	SUPPL	24	AP	2022-08-17
REMS; REMS	SUPPL	25	AP	2022-12-08

Submissions Property Types

ORIG	1	Null	42
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	15	Null	15
SUPPL	16	Null	15
SUPPL	17	Null	15
SUPPL	22	Null	15
SUPPL	24	Null	15
SUPPL	25	Null	7

TE Codes

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

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78907
            [companyName] => SPECGX LLC
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2009\/078907MedGuide.pdf"]
            [products] => [{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.2MG BASE","dosageForm":"TROCHE\/LOZENGE;TRANSMUCOSAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.4MG BASE","dosageForm":"TROCHE\/LOZENGE;TRANSMUCOSAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.6MG BASE","dosageForm":"TROCHE\/LOZENGE;TRANSMUCOSAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.8MG BASE","dosageForm":"TROCHE\/LOZENGE;TRANSMUCOSAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 1.2MG BASE","dosageForm":"TROCHE\/LOZENGE;TRANSMUCOSAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 1.6MG BASE","dosageForm":"TROCHE\/LOZENGE;TRANSMUCOSAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FENTANYL CITRATE","submission":"FENTANYL CITRATE","actionType":"EQ 0.2MG BASE","submissionClassification":"TROCHE\/LOZENGE;TRANSMUCOSAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENTANYL CITRATE","submission":"FENTANYL CITRATE","actionType":"EQ 0.4MG BASE","submissionClassification":"TROCHE\/LOZENGE;TRANSMUCOSAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENTANYL CITRATE","submission":"FENTANYL CITRATE","actionType":"EQ 0.6MG BASE","submissionClassification":"TROCHE\/LOZENGE;TRANSMUCOSAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENTANYL CITRATE","submission":"FENTANYL CITRATE","actionType":"EQ 0.8MG BASE","submissionClassification":"TROCHE\/LOZENGE;TRANSMUCOSAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENTANYL CITRATE","submission":"FENTANYL CITRATE","actionType":"EQ 1.2MG BASE","submissionClassification":"TROCHE\/LOZENGE;TRANSMUCOSAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENTANYL CITRATE","submission":"FENTANYL CITRATE","actionType":"EQ 1.6MG BASE","submissionClassification":"TROCHE\/LOZENGE;TRANSMUCOSAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)