Data updated: Jun 12, 2026
CHLOR-TRIMETON (chlorpheniramine maleate)
Respiratory
Approved 1949-07-13
5
Indications
--
Phase 3 Trials
76
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1949-07-13
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET, SYRUP, INJECTABLE
Companies
Website: ↗
CHLOR-TRIMETON Approval History
1950
1951
1952
1953
1954
1955
1956
1957
1958
1959
1960
1961
1962
1963
1964
1965
1966
1967
1968
1969
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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
78 FDA actions from 1949 to 2015 · 1 indication expansions
Mar 2002 SUPPL
Mfg
Nov 2001 SUPPL
Mfg
Jul 2001 SUPPL
Mfg
Jan 2001 SUPPL
Mfg
Oct 2000 SUPPL
Mfg
May 2000 SUPPL
Mfg
Apr 2000 SUPPL
Mfg
Nov 1998 SUPPL
Mfg
Oct 1998 SUPPL
Mfg
Sep 1998 SUPPL
Mfg
Oct 1997 SUPPL
Label
Jan 1989 SUPPL
Mfg
Jul 1986 SUPPL
Mfg
Jan 1986 SUPPL
Label
Oct 1984 SUPPL
Label
Oct 1984 SUPPL
Label
Sep 1984 SUPPL
Mfg
Feb 1983 SUPPL
Mfg
Jan 1983 SUPPL
Label
Aug 1982 SUPPL
Mfg
May 1982 SUPPL
Efficacy
Oct 1981 SUPPL
Label
May 1981 SUPPL
Mfg
Mar 1981 ORIGINAL
Update
Jul 1980 SUPPL
Mfg
Jul 1980 SUPPL
Mfg
Jun 1980 SUPPL
Mfg
Feb 1980 SUPPL
Mfg
Dec 1979 SUPPL
Label
Sep 1979 SUPPL
Label
Jan 1979 SUPPL
Mfg
Oct 1978 SUPPL
Label
Sep 1978 SUPPL
Label
Jun 1978 SUPPL
Label
Aug 1950 ORIGINAL
New Form
Jul 1949 ORIGINAL
Update
What CHLOR-TRIMETON Treats
5 FDA approvalsOriginally approved for its first indication in 1949 . Covers 5 distinct patient populations.
- Other (5)
Other
(5 approvals)- • Approved indication (Jul 1949)
- • Approved indication (Aug 1950)
- • Approved indication (Mar 1981)
- • Approved indication (May 1982)
- • Approved indication (Jan 1986)
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Pro Key Completed Trials
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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.
CHLOR-TRIMETON FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.