Fentanyl Oral Lozenge

Brand(s)
Actiq
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Cephalon, Incorporated (2011-12-28)
Oldest Current Product
1998-11-04
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL LOZENGE\FENTANYL
FDAOB
TRANSMUCOSAL\TROCHE/LOZENGE\FENTANYL CITRATE\rdfq
SPL Active
ORAL\LOZENGE\FENTANYL CITRATE
TRANSMUCOSAL\LOZENGE\FENTANYL CITRATE
SPL Moiety
ORAL\LOZENGE\FENTANYL
TRANSMUCOSAL\LOZENGE\FENTANYL

product(s) by strength(s)

fentanyl 0.2 mg oral lozenge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634590502ActiqNDACephalon, Incorporated1998-11-04FENTANYL CITRATEORALLOZENGENDA02074790b94524-f913-48b3-3771-7b2fcffd888a

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000937865NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc2015-11-18FENTANYL CITRATEORALLOZENGENDA02074778221eab-66fd-4cd8-9c81-af52eb83671c
2004069202ANDAMallinckrodt, Inc.2010-01-15FENTANYL CITRATETRANSMUCOSALLOZENGEANDA078907552ba162-76ed-4bc9-8c2c-fac7a1804da0
3498840459ANDAPar Pharmaceutical Companies, Inc.2011-10-17FENTANYL CITRATEORALLOZENGEANDA0773127b16f79f-33dd-4375-9f5f-b931aecf7ab8
4552530070NDA AUTHORIZED GENERICCima Labs Inc.1999-01-202017-11-30FENTANYL CITRATETRANSMUCOSALLOZENGENDA020747ea24ac91-d2df-2933-bd34-708c3b11a4c5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686025NDAPhysicians Total Care, Inc.2009-04-24FENTANYL CITRATEORALLOZENGE552530070NDA020747b910cff4-22a4-4b39-b872-0bd1312f4d8b

fentanyl 0.4 mg oral lozenge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634590504ActiqNDACephalon, Incorporated1998-11-04FENTANYL CITRATEORALLOZENGENDA02074790b94524-f913-48b3-3771-7b2fcffd888a

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000937866NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc2015-11-18FENTANYL CITRATEORALLOZENGENDA02074778221eab-66fd-4cd8-9c81-af52eb83671c
2004069204ANDAMallinckrodt, Inc.2010-01-15FENTANYL CITRATETRANSMUCOSALLOZENGEANDA078907552ba162-76ed-4bc9-8c2c-fac7a1804da0
3498840460ANDAPar Pharmaceutical Companies, Inc.2011-10-17FENTANYL CITRATEORALLOZENGEANDA0773127b16f79f-33dd-4375-9f5f-b931aecf7ab8
4552530071NDA AUTHORIZED GENERICCima Labs Inc.1999-01-202016-10-31FENTANYL CITRATETRANSMUCOSALLOZENGENDA020747ea24ac91-d2df-2933-bd34-708c3b11a4c5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1529590549NDAH.J. Harkins Company, Inc.2006-09-06FENTANYL CITRATEORALLOZENGE552530071NDA020747e4ce209d-3f8c-4ac4-bec1-2525a93708bc
2548685975NDAPhysicians Total Care, Inc.2008-12-19FENTANYL CITRATEORALLOZENGE552530071NDA020747b910cff4-22a4-4b39-b872-0bd1312f4d8b

fentanyl 0.6 mg oral lozenge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634590506ActiqNDACephalon, Incorporated1998-11-04FENTANYL CITRATEORALLOZENGENDA02074790b94524-f913-48b3-3771-7b2fcffd888a

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000937867NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc2015-11-18FENTANYL CITRATEORALLOZENGENDA02074778221eab-66fd-4cd8-9c81-af52eb83671c
2004069206ANDAMallinckrodt, Inc.2010-01-15FENTANYL CITRATETRANSMUCOSALLOZENGEANDA078907552ba162-76ed-4bc9-8c2c-fac7a1804da0
3498840461ANDAPar Pharmaceutical Companies, Inc.2011-10-17FENTANYL CITRATEORALLOZENGEANDA0773127b16f79f-33dd-4375-9f5f-b931aecf7ab8
4552530072NDA AUTHORIZED GENERICCima Labs Inc.1999-01-202016-10-31FENTANYL CITRATETRANSMUCOSALLOZENGENDA020747ea24ac91-d2df-2933-bd34-708c3b11a4c5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1529590548NDAH.J. Harkins Company, Inc.2006-09-06FENTANYL CITRATEORALLOZENGE552530072NDA020747e4ce209d-3f8c-4ac4-bec1-2525a93708bc
2548686026NDAPhysicians Total Care, Inc.2009-04-24FENTANYL CITRATEORALLOZENGE552530072NDA020747b910cff4-22a4-4b39-b872-0bd1312f4d8b

fentanyl 0.8 mg oral lozenge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634590508ActiqNDACephalon, Incorporated1998-11-04FENTANYL CITRATEORALLOZENGENDA02074790b94524-f913-48b3-3771-7b2fcffd888a

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000937868NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc2015-11-18FENTANYL CITRATEORALLOZENGENDA02074778221eab-66fd-4cd8-9c81-af52eb83671c
2004069208ANDAMallinckrodt, Inc.2010-01-15FENTANYL CITRATETRANSMUCOSALLOZENGEANDA078907552ba162-76ed-4bc9-8c2c-fac7a1804da0
3498840462ANDAPar Pharmaceutical Companies, Inc.2011-10-17FENTANYL CITRATEORALLOZENGEANDA0773127b16f79f-33dd-4375-9f5f-b931aecf7ab8
4552530073NDA AUTHORIZED GENERICCima Labs Inc.1999-01-202017-12-31FENTANYL CITRATETRANSMUCOSALLOZENGENDA020747ea24ac91-d2df-2933-bd34-708c3b11a4c5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560999ANDALake Erie Medical Dba Quality Care Products Llc2011-10-17FENTANYL CITRATEORALLOZENGE498840462ANDA0773128c3a8b2e-3ec2-4fad-bb9f-838822d97e6f
2548686027NDAPhysicians Total Care, Inc.2009-04-24FENTANYL CITRATEORALLOZENGE552530073NDA020747b910cff4-22a4-4b39-b872-0bd1312f4d8b

fentanyl 1.2 mg oral lozenge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634590512ActiqNDACephalon, Incorporated1998-11-04FENTANYL CITRATEORALLOZENGENDA02074790b94524-f913-48b3-3771-7b2fcffd888a

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000937869NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc2015-11-18FENTANYL CITRATEORALLOZENGENDA02074778221eab-66fd-4cd8-9c81-af52eb83671c
2004069212ANDAMallinckrodt, Inc.2010-01-15FENTANYL CITRATETRANSMUCOSALLOZENGEANDA078907552ba162-76ed-4bc9-8c2c-fac7a1804da0
3498840463ANDAPar Pharmaceutical Companies, Inc.2011-10-17FENTANYL CITRATEORALLOZENGEANDA0773127b16f79f-33dd-4375-9f5f-b931aecf7ab8
4552530074NDA AUTHORIZED GENERICCima Labs Inc.1999-01-202016-11-30FENTANYL CITRATETRANSMUCOSALLOZENGENDA020747ea24ac91-d2df-2933-bd34-708c3b11a4c5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1529590566NDAH.J. Harkins Company, Inc.2006-09-06FENTANYL CITRATEORALLOZENGE552530074NDA020747e4ce209d-3f8c-4ac4-bec1-2525a93708bc
2548686037NDAPhysicians Total Care, Inc.2009-06-05FENTANYL CITRATEORALLOZENGE552530074NDA020747b910cff4-22a4-4b39-b872-0bd1312f4d8b

fentanyl 1.6 mg oral lozenge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634590516ActiqNDACephalon, Incorporated1998-11-04FENTANYL CITRATEORALLOZENGENDA02074790b94524-f913-48b3-3771-7b2fcffd888a

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000937870NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc2015-11-18FENTANYL CITRATEORALLOZENGENDA02074778221eab-66fd-4cd8-9c81-af52eb83671c
2004069216ANDAMallinckrodt, Inc.2010-01-15FENTANYL CITRATETRANSMUCOSALLOZENGEANDA078907552ba162-76ed-4bc9-8c2c-fac7a1804da0
3498840464ANDAPar Pharmaceutical Companies, Inc.2011-10-17FENTANYL CITRATEORALLOZENGEANDA0773127b16f79f-33dd-4375-9f5f-b931aecf7ab8
4552530075NDA AUTHORIZED GENERICCima Labs Inc.1999-01-202016-10-31FENTANYL CITRATETRANSMUCOSALLOZENGENDA020747ea24ac91-d2df-2933-bd34-708c3b11a4c5

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA077312FENTANYL CITRATEPAR PHARMACEUTICAL INC2009-10-30ANDA077312_001, ANDA077312_002, ANDA077312_003, ANDA077312_004, ANDA077312_005, ANDA077312_006
2ANDA078907FENTANYL CITRATEMALLINCKRODT INC2009-10-30ANDA078907_001, ANDA078907_002, ANDA078907_003, ANDA078907_004, ANDA078907_005, ANDA078907_006
3NDA020747ACTIQCEPHALON INC1998-11-04NDA020747_001, NDA020747_002, NDA020747_003, NDA020747_004, NDA020747_005, NDA020747_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routerldTEapprovedapplication
1ANDA077312_001RXFENTANYL CITRATE (EQ 0.2MG BASE)TRANSMUCOSALFalseAB2009-10-30FENTANYL CITRATE
2ANDA077312_002RXFENTANYL CITRATE (EQ 0.4MG BASE)TRANSMUCOSALFalseAB2009-10-30FENTANYL CITRATE
3ANDA077312_003RXFENTANYL CITRATE (EQ 0.6MG BASE)TRANSMUCOSALFalseAB2009-10-30FENTANYL CITRATE
4ANDA077312_004RXFENTANYL CITRATE (EQ 0.8MG BASE)TRANSMUCOSALFalseAB2009-10-30FENTANYL CITRATE
5ANDA077312_005RXFENTANYL CITRATE (EQ 1.2MG BASE)TRANSMUCOSALFalseAB2009-10-30FENTANYL CITRATE
6ANDA077312_006RXFENTANYL CITRATE (EQ 1.6MG BASE)TRANSMUCOSALFalseAB2009-10-30FENTANYL CITRATE
7ANDA078907_001RXFENTANYL CITRATE (EQ 0.2MG BASE)TRANSMUCOSALFalseAB2009-10-30FENTANYL CITRATE
8ANDA078907_002RXFENTANYL CITRATE (EQ 0.4MG BASE)TRANSMUCOSALFalseAB2009-10-30FENTANYL CITRATE
9ANDA078907_003RXFENTANYL CITRATE (EQ 0.6MG BASE)TRANSMUCOSALFalseAB2009-10-30FENTANYL CITRATE
10ANDA078907_004RXFENTANYL CITRATE (EQ 0.8MG BASE)TRANSMUCOSALFalseAB2009-10-30FENTANYL CITRATE
11ANDA078907_005RXFENTANYL CITRATE (EQ 1.2MG BASE)TRANSMUCOSALFalseAB2009-10-30FENTANYL CITRATE
12ANDA078907_006RXFENTANYL CITRATE (EQ 1.6MG BASE)TRANSMUCOSALFalseAB2009-10-30FENTANYL CITRATE
13NDA020747_001RXFENTANYL CITRATE (EQ 0.2MG BASE)TRANSMUCOSALFalseAB1998-11-04ACTIQ
14NDA020747_002RXFENTANYL CITRATE (EQ 0.4MG BASE)TRANSMUCOSALTrueAB1998-11-04ACTIQ
15NDA020747_003RXFENTANYL CITRATE (EQ 0.6MG BASE)TRANSMUCOSALFalseAB1998-11-04ACTIQ
16NDA020747_004RXFENTANYL CITRATE (EQ 0.8MG BASE)TRANSMUCOSALFalseAB1998-11-04ACTIQ
17NDA020747_005RXFENTANYL CITRATE (EQ 1.2MG BASE)TRANSMUCOSALFalseAB1998-11-04ACTIQ
18NDA020747_006RXFENTANYL CITRATE (EQ 1.6MG BASE)TRANSMUCOSALFalseAB1998-11-04ACTIQ

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1552ba162-76ed-4bc9-8c2c-fac7a1804da0 (view SPL)These highlights do not include all the information needed to use oral transmucosal fentanyl citrate safely and effectively. See full prescribing information for oral transmucosal fentanyl citrate. Oral Transmucosal Fentanyl Citrate, oral transmucosal, CII Initial U.S. Approval: 1968prescriptionHuman PrescriptionMallinckrodt, Inc.analysis, api manufacture, manufacture2012-02-2311004069202, 004069204, 004069206, 004069208, 004069212, 004069216
278221eab-66fd-4cd8-9c81-af52eb83671c (view SPL)These highlights do not include all the information needed to use Oral Transmucosal Fentanyl Citrate (OTFC) safely and effectively. See full prescribing information for OTFC. Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge, CII Initial U.S. Approval: 1968prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-11-181000937865, 000937866, 000937867, 000937868, 000937869, 000937870
37b16f79f-33dd-4375-9f5f-b931aecf7ab8 (view SPL)These highlights do not include all the information needed to use Oral Transmucosal Fentanyl Citrate (OTFC) safely and effectively. See full prescribing information for OTFC.Oral Transmucosal Fentanyl Citrate (OTFC), CIIInitial U.S. Approval: 1968prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.LABEL, MANUFACTURE2014-04-084498840459, 498840460, 498840461, 498840462, 498840463, 498840464
48c3a8b2e-3ec2-4fad-bb9f-838822d97e6f (view SPL)These highlights do not include all the information needed to use Oral Transmucosal Fentanyl Citrate (OTFC) safely and effectively. See full prescribing information for OTFC.Oral Transmucosal Fentanyl Citrate (OTFC), CIIInitial U.S. Approval: 1968prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2013-08-201353560999
590b94524-f913-48b3-3771-7b2fcffd888a (view SPL)These highlights do not include all the information needed to use ACTIQ safely and effectively. See full prescribing information for ACTIQ. ACTIQ (fentanyl citrate) oral transmucosal lozenge, CII Initial U.S. Approval: 1968prescriptionHuman PrescriptionCephalon, IncorporatedANALYSIS, MANUFACTURE2011-12-287634590502, 634590504, 634590506, 634590508, 634590512, 634590516
6b910cff4-22a4-4b39-b872-0bd1312f4d8b (view SPL)These highlights do not include all the information needed to use Oral Transmucosal Fentanyl Citrate (OTFC) safely and effectively. See full prescribing information for OTFC. Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge, CII Initial U.S. Approval: 1968prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-03-172548685975, 548686025, 548686026, 548686027, 548686037
7e4ce209d-3f8c-4ac4-bec1-2525a93708bc (view SPL)These highlights do not include all the information needed to use Oral Transmucosal Fentanyl Citrate (OTFC) safely and effectively. See full prescribing information for OTFC. Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge, CII Initial U.S. Approval: 1968prescriptionHuman PrescriptionH.J. Harkins Company, Inc.analysis, manufacture2011-09-061529590548, 529590549, 529590566
8ea24ac91-d2df-2933-bd34-708c3b11a4c5 (view SPL)These highlights do not include all the information needed to use Oral Transmucosal Fentanyl Citrate (OTFC) safely and effectively. See full prescribing information for OTFC. Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge, CII Initial U.S. Approval: 1968prescriptionHuman PrescriptionCima Labs Inc.2015-10-0212552530070, 552530071, 552530072, 552530073, 552530074, 552530075

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII