Data updated: Mar 10, 2026
FENTANYL CITRATE
FENTANYL CITRATE
Approved 1984-07-11
9
Indications
--
Phase 3 Trials
41
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1984-07-11
- Routes
- BUCCAL, SUBLINGUAL, INJECTION, TRANSMUCOSAL, SUBLINGUAL, INTRAVENOUS
- Dosage Forms
- TABLET, INJECTABLE, TROCHE/LOZENGE, SOLUTION
FENTANYL CITRATE Approval History
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What FENTANYL CITRATE Treats
9 FDA approvalsOriginally approved for its first indication in 1984 . Covers 9 distinct patient populations.
- Other (9)
Other
(9 approvals)- • Approved indication (Jul 1984)
- • Approved indication (Jan 1985)
- • Approved indication (Apr 1990)
- • Approved indication (Oct 2009)Label Letter
- • Approved indication (Jan 2011)Letter
- • Approved indication (Nov 2017)Letter
- • Approved indication (Sep 2020)
- • Approved indication (Aug 2022)
- • Approved indication (Feb 2023)Label Letter
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FENTANYL CITRATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.