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FDA NDA · NDA021947

FENTORA

Sponsor: CEPHALON

APPLICATION
NDA021947
TYPE
NDA
ORIGINAL APPROVAL
2006-09-25
LATEST ACTION
2025-12-22
ROUTE
BUCCAL, SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FENTORA · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · BUCCAL, SUBLINGUAL
FENTORA · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · BUCCAL, SUBLINGUAL
FENTORA · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · BUCCAL, SUBLINGUAL
FENTORA · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · BUCCAL, SUBLINGUAL
FENTORA · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · BUCCAL, SUBLINGUAL
FENTORA · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · BUCCAL, SUBLINGUAL

Approval history

2025-12-22Labeling · Supplement 46 · standard — Letter ↗AP
2024-08-28REMS · Supplement 45 — Letter ↗AP
2023-12-15Labeling · Supplement 43 · standard — Label ↗AP
2022-12-08REMS · Supplement 42 — Letter ↗AP
2022-11-22REMS · Supplement 38 — Label ↗AP
2022-08-17REMS · Supplement 40 — Letter ↗AP
2021-12-03REMS · Supplement 37 — Letter ↗AP
2021-03-04Labeling · Supplement 34 · standard — Letter ↗AP
2020-12-23REMS · Supplement 30 — Letter ↗AP
2019-10-07Labeling · Supplement 29 · standard — Letter ↗AP
2017-09-07REMS · Supplement 27 — Letter ↗AP
2017-04-11REMS · Supplement 19 — Label ↗AP
2017-01-12Manufacturing (CMC) · Supplement 26 · standardAP
2016-12-16Labeling · Supplement 24 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 25 · standard — Letter ↗AP
2016-05-19Manufacturing (CMC) · Supplement 14 · standardAP
2014-12-24REMS · Supplement 22 — Letter ↗AP
2014-08-29Manufacturing (CMC) · Supplement 21 · standardAP
2013-11-07REMS · Supplement 17 — Letter ↗AP
2013-02-21Efficacy · Supplement 8 · standard — Label ↗AP
2012-06-05REMS · Supplement 15 — Label ↗AP
2011-12-28REMS · Supplement 13 — Letter ↗AP
2011-07-20Labeling · Supplement 9 · standard — Label ↗AP
2011-01-20Labeling · Supplement 11 · standard — Letter ↗AP
2009-12-02Labeling · Supplement 10 · standard — Letter ↗AP
2008-02-07Labeling · Supplement 6 · standard — Letter ↗AP
2007-04-27Labeling · Supplement 1 · standard — Label ↗AP
2007-03-02Manufacturing (CMC) · Supplement 2 — Label ↗AP
2006-09-25Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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