Data updated: Jun 17, 2026
MPI INDIUM DTPA IN 111 (indium in-111 pentetate disodium)
Radiopharmaceutical Activity
Other
Approved 1982-02-18
Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography.
Source: FDA Label • GE HEALTHCARE
1
Indication
--
Phase 3 Trials
44
Years on Market
Details
- Status
- Prescription
- First Approved
- 1982-02-18
- Routes
- INTRATHECAL
- Dosage Forms
- INJECTABLE
MPI INDIUM DTPA IN 111 Approval History
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Original
New Indication
New Form
Label Update
9 FDA actions from 1982 to 2016
Dec 2016 SUPPL
Mfg · Manufacturing (CMC)
Apr 2002 SUPPL
Mfg · Manufacturing (CMC)
Jan 1996 SUPPL
Label
May 1995 SUPPL
Mfg
Feb 1995 SUPPL
Mfg
May 1985 SUPPL
Label
Sep 1984 SUPPL
Mfg
Feb 1982 ORIGINAL
New Drug
What MPI INDIUM DTPA IN 111 Treats
1 FDA approvalsOriginally approved for its first indication in 1982 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 1982)
GE HEALTHCARE's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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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.
MPI INDIUM DTPA IN 111 FDA Label Details
Indications & Usage
Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.