TheraRadar
Data updated: Jul 17, 2026

HY-PAM "25" (hydroxyzine pamoate) · Teva

Trial Activity: Mature 1 active trials
CNS Approved 1985-03-04

HY-PAM "25" is FDA-approved to treat 6 conditions (same as HYDROXYZINE PAMOATE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

University of Washington conducting 1 trials (17%)
15 indications explored (Broad Platform)
→ dental caries in children (1 trials)
→ pediatric dental sedation (1 trials)
→ meperidine (1 trials)
1
Indication
--
Phase 3 Trials
41
Years on Market

Details

Status
Discontinued
First Approved
1985-03-04
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Teva
Active Ingredient: HYDROXYZINE PAMOATE

HY-PAM "25" Approval History

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Original
New Indication
New Form
Label Update
1 FDA actions from 1985 to 1985
Mar 1985 ORIGINAL
Update · Not Applicable

What HY-PAM "25" Treats

6 indications

HY-PAM "25" is approved for 6 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as HYDROXYZINE PAMOATE (same active ingredient).

Source: FDA Label

Teva's other novel FDA approvals

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

AJOVY
2018
FREMANEZUMAB-VFRM
1 designation
AUSTEDO
2017
DEUTETRABENAZINE
1 designation
CINQAIR
2016
RESLIZUMAB
1 designation
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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

ClinicalTrials.gov ↗ Pro

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.

HY-PAM "25" FDA Label Details

Indications & Usage

HY-PAM "25" is FDA-approved to treat 6 conditions — same approved indications as HYDROXYZINE PAMOATE.

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Data Sources

FDA Approval: ANDA088713 → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment