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Data updated: Sep 20, 2026

ULTRATAG (technetium tc-99m red blood cell kit) · CURIUM

Other Approved 1991-06-10

ULTRATAG is FDA-approved to treat 1 condition.

1
Indication
--
Phase 3 Trials
35
Years on Market

Details

Status
Prescription
First Approved
1991-06-10
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

ULTRATAG Approval History

1992
1993
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2000
2001
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Original
New Indication
New Form
Label Update
8 FDA actions from 1991 to 2026
Aug 2026 SUPPL
Mfg · Manufacturing (CMC)
Sep 2014 SUPPL
Mfg · Manufacturing (CMC)
Apr 2000 SUPPL
Mfg · Manufacturing (CMC)

What ULTRATAG Treats

1 indications

ULTRATAG is approved for 1 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Gastrointestinal Bleeding
Source: FDA Label

ULTRATAG Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

1

Same indication, different mechanism — what else might this patient receive?

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ULTRATAG

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Shared indications:
Gastrointestinal Bleeding

CURIUM's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

ULTRATAG FDA Label Details

Indications & Usage

FDA Label (PDF)

ULTRATAG is FDA-approved to treat 1 condition.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.