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Data updated: Mar 10, 2026

HYDROXYZINE PAMOATE

HYDROXYZINE PAMOATE
Neurology Approved 1981-12-14
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
13
Indications
--
Phase 3 Trials
44
Years on Market

Details

Status
Prescription
First Approved
1981-12-14
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Novartis Teva SUPERPHARM WATSON LABS IVAX SUB TEVA PHARMS VANGARD HERITAGE PHARMA BEXIMCO PHARMS USA PAR PHARM IMPAX LABS INC DURAMED PHARMS BARR
Active Ingredient: HYDROXYZINE PAMOATE

HYDROXYZINE PAMOATE Approval History

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What HYDROXYZINE PAMOATE Treats

6 indications

HYDROXYZINE PAMOATE is approved for 6 conditions since its original approval in 1981. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Anxiety
  • Psychoneurosis
  • Pruritus
  • Urticaria
  • Atopic Dermatitis
  • Contact Dermatitis
Source: FDA Label

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Trial Timeline

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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.

HYDROXYZINE PAMOATE FDA Label Details

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Indications & Usage

INDICATIONS For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol ® ) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloi...

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Data Sources

FDA Approval: ANDA087479 → Label: DailyMed → Trials: ClinicalTrials.gov →

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