FDA.reportPublic FDA data

Application 021947

Type
NDA
Sponsor
CEPHALON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENTORAFENTANYL CITRATETABLET;BUCCAL, SUBLINGUALEQ 0.1MG BASEYesNo
002FENTORAFENTANYL CITRATETABLET;BUCCAL, SUBLINGUALEQ 0.2MG BASEYesNo
003FENTORAFENTANYL CITRATETABLET;BUCCAL, SUBLINGUALEQ 0.4MG BASEYesYes
004FENTORAFENTANYL CITRATETABLET;BUCCAL, SUBLINGUALEQ 0.6MG BASEYesNo
005FENTORAFENTANYL CITRATETABLET;BUCCAL, SUBLINGUALEQ 0.8MG BASEYesNo
006FENTORAFENTANYL CITRATETABLET;BUCCAL, SUBLINGUALEQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-634Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-634Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-634Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-634Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-635Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-635Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-635Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-635Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-636Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-636Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-636Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-636Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-637Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-637Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-637Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-637Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-638Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-638Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-638Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
51862-638Fentanyl BuccalFentanyl CitrateMayne PharmaNDA AUTHORIZED GENERICCurrent
63459-541FENTORAFentanylCephalon, LLCNDACurrent
63459-541FENTORAFentanylCephalon, LLCNDACurrent
63459-541FENTORAFentanylCephalon, Inc.NDACurrent
63459-541FENTORAFentanylCephalon, Inc.NDACurrent
63459-541FENTORAFentanylCephalon, LLCNDACurrent
63459-541FENTORAFentanylCephalon, Inc.NDACurrent
63459-541FENTORAFentanylCephalon, Inc.NDACurrent
63459-541FENTORAFentanylCephalon, Inc.NDACurrent
63459-541FENTORAFentanylCephalon, Inc.NDACurrent
63459-542FENTORAFentanylCephalon, Inc.NDACurrent
63459-542FENTORAFentanylCephalon, Inc.NDACurrent
63459-542FENTORAFentanylCephalon, Inc.NDACurrent
63459-542FENTORAFentanylCephalon, Inc.NDACurrent
63459-542FENTORAFentanylCephalon, Inc.NDACurrent
63459-542FENTORAFentanylCephalon, Inc.NDACurrent
63459-542FENTORAFentanylCephalon, LLCNDACurrent
63459-542FENTORAFentanylCephalon, LLCNDACurrent
63459-542FENTORAFentanylCephalon, LLCNDACurrent
63459-544FENTORAFentanylCephalon, Inc.NDACurrent
63459-544FENTORAFentanylCephalon, Inc.NDACurrent
63459-544FENTORAFentanylCephalon, Inc.NDACurrent
63459-544FENTORAFentanylCephalon, Inc.NDACurrent
63459-544FENTORAFentanylCephalon, LLCNDACurrent
63459-544FENTORAFentanylCephalon, Inc.NDACurrent
63459-544FENTORAFentanylCephalon, Inc.NDACurrent
63459-544FENTORAFentanylCephalon, LLCNDACurrent
63459-544FENTORAFentanylCephalon, LLCNDACurrent
63459-546FENTORAFentanylCephalon, Inc.NDACurrent
63459-546FENTORAFentanylCephalon, Inc.NDACurrent
63459-546FENTORAFentanylCephalon, Inc.NDACurrent
63459-546FENTORAFentanylCephalon, Inc.NDACurrent
63459-546FENTORAFentanylCephalon, Inc.NDACurrent
63459-546FENTORAFentanylCephalon, LLCNDACurrent
63459-546FENTORAFentanylCephalon, Inc.NDACurrent
63459-546FENTORAFentanylCephalon, LLCNDACurrent
63459-546FENTORAFentanylCephalon, LLCNDACurrent
63459-548FENTORAFentanylCephalon, LLCNDACurrent
63459-548FENTORAFentanylCephalon, LLCNDACurrent
63459-548FENTORAFentanylCephalon, Inc.NDACurrent
63459-548FENTORAFentanylCephalon, Inc.NDACurrent
63459-548FENTORAFentanylCephalon, LLCNDACurrent
63459-548FENTORAFentanylCephalon, Inc.NDACurrent
63459-548FENTORAFentanylCephalon, Inc.NDACurrent
63459-548FENTORAFentanylCephalon, Inc.NDACurrent
63459-548FENTORAFentanylCephalon, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84688SUPPL 2026-01-06
84604SUPPL 2025-12-31
79502SUPPL 2024-08-29
77006SUPPL 2023-12-19
76918SUPPL 2023-12-18
76917SUPPL 2023-12-18
72848SUPPL2022-12-09
72708SUPPL2022-11-25
72679SUPPL2022-11-23
72678SUPPL2022-11-23
71845SUPPL2022-08-18
69494SUPPL2021-12-07
66599SUPPL2021-03-08
66598SUPPL2021-03-08
66554SUPPL2021-03-05
65768SUPPL2020-12-28
60490SUPPL2019-10-09
60489SUPPL2019-10-09
60440SUPPL2019-10-09
49712SUPPL2017-09-11
48027SUPPL2017-04-14
47996SUPPL2017-04-12
46349SUPPL2016-12-21
46348SUPPL2016-12-21
46294SUPPL2016-12-20
46293SUPPL2016-12-20
28909SUPPL2014-12-30
28908SUPPL2013-11-12
16625SUPPL2013-02-26
28905SUPPL2013-02-25
16628SUPPL2012-06-11
28907SUPPL2012-06-07
6522SUPPL2012-01-03
44487ORIG2011-12-30
37938SUPPL2011-12-28
37937SUPPL2011-07-21
28906SUPPL2011-07-21
6521SUPPL2011-01-25
16627SUPPL2011-01-24
6520SUPPL2010-01-25
16626SUPPL2009-12-11
16624SUPPL2008-02-14
6519SUPPL2008-02-14
42355ORIG2007-12-06
23687ORIG2007-09-26
37936SUPPL2007-05-01
6518SUPPL2007-05-01
28904SUPPL2007-03-07
16623SUPPL2007-03-07
6517ORIG2006-10-02
37935ORIG2006-09-26