Data updated: Mar 10, 2026
METOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE
Approved 1985-07-29
37
Indications
--
Phase 3 Trials
40
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1985-07-29
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, SOLUTION, INJECTABLE, TABLET, ORALLY DISINTEGRATING
Companies
NORTHSTAR HLTHCARE WATSON LABS MORTON GROVE Pfizer STRIDES PHARMA INTL Teva PACO BEDFORD Novartis CHARTWELL MOLECULAR Merck HALSEY SUPERPHARM CLONMEL PHARMOBEDIENT CNSLTG IPCA LABS LTD NOVEL LABS INC LYPHOMED INTERPHARM SMITH AND NEPHEW VISTAPHARM LLC PAR PHARM MUTUAL PHARM NORBROOK ANI PHARMS Sun Pharma AIPING PHARM INC Fresenius Kabi USL PHARMA IMPAX LABS INC ROXANE GENUS CHARTWELL RX
Active Ingredient: METOCLOPRAMIDE HYDROCHLORIDE
Website: ↗
METOCLOPRAMIDE HYDROCHLORIDE Approval History
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What METOCLOPRAMIDE HYDROCHLORIDE Treats
37 FDA approvalsOriginally approved for its first indication in 1985 . Covers 37 distinct patient populations.
- Other (37)
Other
(37 approvals)- • Approved indication (Jul 1985)
- • Approved indication (Oct 1985)
- • Approved indication (Jan 1986)
- • Approved indication (Jan 1986)
- • Approved indication (Feb 1987)
- • Approved indication (Feb 1987)
- • Approved indication (Mar 1987)
- • Approved indication (Jun 1987)
- • Approved indication (Jul 1987)
- • Approved indication (Feb 1988)
- • Approved indication (Aug 1988)
- • Approved indication (Aug 1988)
- • Approved indication (Nov 1988)
- • Approved indication (Dec 1988)
- • Approved indication (Mar 1989)
- • Approved indication (Jun 1989)
- • Approved indication (Jun 1989)
- • Approved indication (Jan 1990)
- • Approved indication (Jan 1991)
- • Approved indication (May 1991)
- • Approved indication (May 1991)
- • Approved indication (Nov 1991)
- • Approved indication (Oct 1992)
- • Approved indication (Apr 1993)
- • Approved indication (Jun 1993)
- • Approved indication (Jun 1993)
- • Approved indication (Jun 1993)
- • Approved indication (Jun 1993)
- • Approved indication (Oct 1995)
- • Approved indication (Aug 1996)
- • Approved indication (Oct 1997)
- • Approved indication (Jan 2001)Label Letter
- • Approved indication (Aug 2006)
- • Approved indication (Nov 2007)
- • Approved indication (Jun 2008)
- • Approved indication (Apr 2013)
- • Approved indication (Aug 2014)Letter
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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.
METOCLOPRAMIDE HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.