Data updated: May 26, 2026
IMIPENEM AND CILASTATIN (cilastatin sodium)
Infectious Disease
Approved 2011-11-16
3
Indications
--
Phase 3 Trials
14
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2011-11-16
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
Companies
Website: ↗
IMIPENEM AND CILASTATIN Approval History
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
31 FDA actions from 2011 to 2024
Apr 2024 SUPPL
Label · Labeling
Feb 2024 SUPPL
Label · Labeling
Dec 2019 ORIGINAL
Update
Jul 2019 SUPPL
Label
May 2019 SUPPL
Label
Dec 2015 SUPPL
Label
Jun 2015 SUPPL
Label
May 2015 SUPPL
Label
Apr 2015 SUPPL
Label
May 2013 SUPPL
Label
Dec 2011 ORIGINAL
Update
What IMIPENEM AND CILASTATIN Treats
3 FDA approvalsOriginally approved for its first indication in 2011 . Covers 3 distinct patient populations.
- Other (3)
Other
(3 approvals)- • Approved indication (Nov 2011)Letter
- • Approved indication (Dec 2011)
- • Approved indication (Dec 2019)
📋
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06886464 PONTiAK | NEPH24-1191 | Ph 2 | recruiting | Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin |
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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.
IMIPENEM AND CILASTATIN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.