Data updated: May 26, 2026
METHERGINE (methylergonovine maleate)
Women's Health
Approved 1946-11-19
5
Indications
--
Phase 3 Trials
79
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1946-11-19
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, TABLET
METHERGINE Approval History
1947
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Original
New Indication
New Form
Label Update
110 FDA actions from 1946 to 2025 · 3 indication expansions
May 2013 SUPPL
Mfg · Manufacturing (CMC)
Feb 2002 SUPPL
Mfg
Jan 2002 SUPPL
Mfg
May 2001 SUPPL
Mfg
Apr 2001 SUPPL
Mfg
Apr 2000 SUPPL
Mfg
Dec 1999 SUPPL
Mfg
Apr 1999 SUPPL
Mfg
Jul 1997 SUPPL
Mfg
May 1997 SUPPL
Label
Feb 1996 SUPPL
Label
Feb 1996 SUPPL
Mfg
Oct 1995 SUPPL
Mfg
Sep 1995 SUPPL
Mfg
Mar 1995 SUPPL
Label
Jul 1994 SUPPL
Mfg
Jul 1994 SUPPL
Mfg
Apr 1994 SUPPL
Label
Mar 1993 SUPPL
Mfg
May 1991 SUPPL
Label
Sep 1990 SUPPL
Mfg
Oct 1989 SUPPL
Mfg
Mar 1989 SUPPL
Mfg
Jul 1987 SUPPL
Mfg
May 1987 SUPPL
Label
Jan 1986 SUPPL
Label
Sep 1985 SUPPL
Label
Jun 1985 SUPPL
Mfg
May 1985 SUPPL
Mfg
Oct 1984 SUPPL
Mfg
Aug 1984 SUPPL
Mfg
Sep 1981 SUPPL
Mfg
Jun 1981 SUPPL
Mfg
Jun 1981 SUPPL
Mfg
Jul 1980 SUPPL
Efficacy
May 1979 SUPPL
Efficacy
Jan 1979 SUPPL
Efficacy
Jan 1979 SUPPL
Mfg
Jun 1977 SUPPL
Mfg
May 1976 SUPPL
Mfg
Jan 1976 SUPPL
Mfg
May 1975 SUPPL
Mfg
Nov 1946 ORIGINAL
Update
What METHERGINE Treats
5 FDA approvalsOriginally approved for its first indication in 1946 . Covers 5 distinct patient populations.
- Other (5)
Other
(5 approvals)- • Approved indication (Nov 1946)
- • Approved indication (Jan 1979)
- • Approved indication (May 1979)
- • Approved indication (Jul 1980)
- • Approved indication (Jun 1981)
📋
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03584854 results posted | 2018P000775-A | Ph 4 | completed | Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial |
| NCT02408965 UPT results posted | UP Trial 2015 | Ph 4 | completed | Uterotonic Prophylaxis Trial |
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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.
METHERGINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.