Data updated: May 26, 2026
IMURAN (azathioprine sodium)
Immunology
Approved 1968-03-20
3
Indications
--
Phase 3 Trials
2
Priority Reviews
58
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1968-03-20
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, TABLET
IMURAN Approval History
1969
1970
1971
1972
1973
1974
1975
1976
1977
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
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2016
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2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
59 FDA actions from 1968 to 2024 · 1 indication expansions
May 2014 SUPPL Priority
Mfg
Sep 1997 SUPPL Priority
Mfg
Nov 1994 SUPPL Priority
Mfg
Aug 1994 SUPPL
Label
Sep 1993 SUPPL Priority
Mfg
Oct 1992 SUPPL Priority
Mfg
Jul 1992 SUPPL Priority
Mfg
Apr 1992 SUPPL Priority
Mfg
Mar 1992 SUPPL Priority
Mfg
Oct 1989 SUPPL Priority
Mfg
May 1988 SUPPL Priority
Mfg
Apr 1988 SUPPL Priority
Mfg
Feb 1987 SUPPL Priority
Mfg
Apr 1982 SUPPL
Label
Apr 1981 SUPPL
Efficacy
Mar 1980 SUPPL Priority
Mfg
Sep 1978 SUPPL Priority
Mfg
Jun 1978 SUPPL Priority
Mfg
Jul 1974 ORIGINAL Priority
New Form
Mar 1968 ORIGINAL Priority
New Drug
What IMURAN Treats
3 FDA approvalsOriginally approved for its first indication in 1968 . Covers 3 distinct patient populations.
- Other (3)
Other
(3 approvals)- • Approved indication (Mar 1968) Priority
- • Approved indication (Jul 1974) Priority
- • Approved indication (Apr 1981)
📋
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02081755 | 013-307 | Ph 4 | enrolling by invitation | Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer |
| NCT05646992 OPRTUNTI | IRB00166167 | Ph 2, Ph 3 | recruiting | Uterus Transplantation to Treat Infertility |
🔬
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.
IMURAN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.