← FDA DRUG APPROVALS

FDA NDA · NDA020747

FENTANYL CITRATE

Sponsor: CEPHALON

APPLICATION
NDA020747
TYPE
NDA
ORIGINAL APPROVAL
1998-11-04
LATEST ACTION
2025-12-22
ROUTE
ORAL, TRANSMUCOSAL
DOSAGE FORM
TROCHE/LOZENGE
MARKETING STATUS
Discontinued

Products

ACTIQ · ReferenceDiscontinued
FENTANYL CITRATE EQ 1.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TROCHE/LOZENGE · TRANSMUCOSAL
ACTIQ · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TROCHE/LOZENGE · TRANSMUCOSAL
ACTIQ · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TROCHE/LOZENGE · TRANSMUCOSAL
ACTIQ · ReferenceDiscontinued
FENTANYL CITRATE EQ 1.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TROCHE/LOZENGE · TRANSMUCOSAL
ACTIQ · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TROCHE/LOZENGE · TRANSMUCOSAL
ACTIQ · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TROCHE/LOZENGE · TRANSMUCOSAL

Approval history

2025-12-22Labeling · Supplement 65 · standard — Letter ↗AP
2024-08-28REMS · Supplement 64 — Letter ↗AP
2023-12-15Labeling · Supplement 62 · standard — Label ↗AP
2022-12-08REMS · Supplement 61 — Letter ↗AP
2022-11-22REMS · Supplement 56 — Label ↗AP
2022-08-17REMS · Supplement 58 — Letter ↗AP
2021-12-03REMS · Supplement 55 — Letter ↗AP
2021-03-04Labeling · Supplement 53 · standard — Letter ↗AP
2020-12-23REMS · Supplement 50 — Letter ↗AP
2019-10-07Labeling · Supplement 49 · standard — Letter ↗AP
2017-09-07REMS · Supplement 47 — Letter ↗AP
2016-12-16Labeling · Supplement 44 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 43 · standard — Letter ↗AP
2014-12-24REMS · Supplement 41 — Letter ↗AP
2014-04-30Manufacturing (CMC) · Supplement 40 · standardAP
2013-11-07REMS · Supplement 37 — Letter ↗AP
2013-04-22Manufacturing (CMC) · Supplement 39 · standardAP
2012-06-05REMS · Supplement 34 — Label ↗AP
2011-12-28REMS · Supplement 33 — Label ↗AP
2011-07-20Labeling · Supplement 29 · standard — Label ↗AP
2009-11-09Labeling · Supplement 30 · standard — Label ↗AP
2007-02-07Efficacy · Supplement 27 · priority — Label ↗AP
2006-09-06Labeling · Supplement 23 · standard — Letter ↗AP
2005-09-09Manufacturing (CMC) · Supplement 19 · standard — Label ↗AP
2005-01-19Labeling · Supplement 18 · standard — Letter ↗AP
2004-09-24Labeling · Supplement 17 · standard — Label ↗AP
2003-02-19Manufacturing (CMC) · Supplement 8 · standard — Letter ↗AP
2003-01-29Labeling · Supplement 9 · standard — Letter ↗AP
2002-06-10Labeling · Supplement 11 · standard — Letter ↗AP
2002-03-12Labeling · Supplement 10 · standard — Letter ↗AP
2001-04-09Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP
2000-08-25Manufacturing (CMC) · Supplement 4 · standardAP
1999-03-26Labeling · Supplement 3 · standard — Review ↗AP
1999-03-26Labeling · Supplement 2 · standardAP
1998-11-04Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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