Data updated: Mar 10, 2026
MEROPENEM
MEROPENEM
Approved 2010-06-22
14
Indications
--
Phase 3 Trials
15
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2010-06-22
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE, POWDER
Companies
DAEWOONG PHARM CO QILU EUGIA PHARMA Novartis GLAND HQ SPCLT PHARMA BROOKS STERISCIENCE Pfizer ACS DOBFAR ACS DOBFAR SPA AMNEAL PHARMS SAVIOR LIFETEC CORP
Active Ingredient: MEROPENEM
Website: ↗
MEROPENEM Approval History
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What MEROPENEM Treats
14 FDA approvalsOriginally approved for its first indication in 2010 . Covers 14 distinct patient populations.
- Other (14)
Other
(14 approvals)- • Approved indication (Jun 2010)
- • Approved indication (Mar 2011)
- • Approved indication (Oct 2011)
- • Approved indication (Dec 2015)Letter
- • Approved indication (Apr 2016)Label Letter
- • Approved indication (Apr 2016)
- • Approved indication (Jun 2016)
- • Approved indication (Jun 2016)
- • Approved indication (Mar 2017)
- • Approved indication (Aug 2019)
- • Approved indication (Aug 2022)
- • Approved indication (Jul 2023)Label Letter
- • Approved indication (Jul 2024)
- • Approved indication (Jun 2025) New
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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.
MEROPENEM FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.