Data updated: May 26, 2026
LEVO-DROMORAN (levorphanol tartrate)
Pain
Approved 1953-01-08
2
Indications
--
Phase 3 Trials
2
Priority Reviews
73
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1953-01-08
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
LEVO-DROMORAN Approval History
1954
1955
1956
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2026
Original
New Indication
New Form
Label Update
31 FDA actions from 1953 to 2004 · 1 indication expansions
Dec 2000 SUPPL Priority
Mfg · Manufacturing (CMC)
Apr 2000 SUPPL Priority
Mfg · Manufacturing (CMC)
Jul 1999 SUPPL Priority
Mfg
Jan 1998 SUPPL Priority
Mfg
Aug 1994 SUPPL Priority
Mfg
Dec 1991 SUPPL Priority
Efficacy
Sep 1989 SUPPL Priority
Mfg
Mar 1989 SUPPL Priority
Mfg
Feb 1986 SUPPL Priority
Mfg
Oct 1985 SUPPL Priority
Mfg
Sep 1985 SUPPL Priority
Mfg
Feb 1985 SUPPL Priority
Mfg
Jun 1984 SUPPL Priority
Label
Sep 1983 SUPPL Priority
Mfg
May 1983 SUPPL Priority
Mfg
Apr 1983 SUPPL Priority
Label
Feb 1983 SUPPL Priority
Mfg
Mar 1982 SUPPL Priority
Mfg
Sep 1981 SUPPL Priority
Mfg
Mar 1981 SUPPL Priority
Mfg
Feb 1981 SUPPL Priority
Mfg
Jun 1979 SUPPL Priority
Mfg
Nov 1978 SUPPL Priority
Mfg
Feb 1978 SUPPL Priority
Mfg
Jan 1953 ORIGINAL Priority
New Form
What LEVO-DROMORAN Treats
2 FDA approvalsOriginally approved for its first indication in 1953 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Jan 1953) Priority
- • Approved indication (Dec 1991) Priority
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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.
LEVO-DROMORAN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.