Data updated: Sep 20, 2026
DEMEROL (meperidine hydrochloride) · Pfizer
Pain
Approved 1942-11-10
1
Indication
--
Phase 3 Trials
83
Years on Market
Details
- Status
- Prescription
- First Approved
- 1942-11-10
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, TABLET, SYRUP
DEMEROL Approval History
1943
1944
1945
1946
1947
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1950
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1952
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2015
2016
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2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
434 FDA actions from 1942 to 2026
Jun 2016 SUPPL
Mfg
Apr 2013 SUPPL
Mfg
Aug 2001 SUPPL
Mfg
Jan 2001 SUPPL
Mfg
Oct 2000 SUPPL
Mfg
Dec 1999 SUPPL
Label
Nov 1998 SUPPL
Mfg
Jul 1997 SUPPL
Label
Oct 1995 SUPPL
Mfg
Mar 1995 SUPPL
Mfg
Sep 1992 SUPPL
Mfg
Sep 1992 SUPPL
Mfg
Jul 1992 SUPPL
Mfg
Feb 1991 SUPPL
Mfg
Sep 1990 SUPPL
Mfg
Jan 1990 SUPPL
Mfg
May 1989 SUPPL
Mfg
May 1989 SUPPL
Mfg
Apr 1989 SUPPL
Mfg
Jan 1988 SUPPL
Label
Jul 1986 SUPPL
Label
May 1986 SUPPL
Mfg
Jun 1985 SUPPL
Mfg
May 1985 SUPPL
Mfg
Jan 1984 SUPPL
Mfg
Mar 1983 SUPPL
Mfg
Sep 1982 SUPPL
Mfg
Jul 1979 SUPPL
Label
Jul 1978 SUPPL
Label
Jul 1978 SUPPL
Label
Jan 1978 SUPPL
Mfg
Dec 1977 SUPPL
Mfg
Aug 1976 SUPPL
Mfg
May 1976 SUPPL
Label
Jan 1974 SUPPL
Label
Nov 1942 ORIGINAL
Update
What DEMEROL Treats
1 FDA approvalsOriginally approved for its first indication in 1942 .
- Other (1)
Other
(1 approval)- • Approved indication (Nov 1942)
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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.
DEMEROL FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.