Overview
An ethanolamine-derivative, first generation histamine H1 antagonist used in hay fever, rhinitis, allergic skin conditions, and pruritus. It causes drowsiness.
Indication
For the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and acrimation. Also for the management of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Used as self-medication for temporary relief of symptoms associated with the common cold.
Associated Conditions
- Allergic Rhinitis (AR)
- Angioedema
- Common Cold
- Urticaria
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/19 | Phase 2 | Not yet recruiting | |||
2024/03/18 | Phase 2 | Not yet recruiting | LMU Klinikum | ||
2024/03/18 | Phase 3 | Recruiting | |||
2023/10/18 | Phase 3 | Recruiting | |||
2023/10/04 | Phase 1 | Not yet recruiting | |||
2023/09/15 | N/A | Completed | |||
2022/05/04 | Phase 1 | Recruiting | |||
2022/04/21 | Phase 3 | Recruiting | Amsterdam UMC, location VUmc | ||
2019/02/01 | Not Applicable | Completed | Chinese Academy of Medical Sciences, Fuwai Hospital | ||
2017/04/12 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| IPG Pharmaceuticals, Inc. | 71085-081 | ORAL | 2.68 mg in 1 1 | 7/30/2025 | |
| Chartwell RX, LLC | 62135-713 | ORAL | 0.67 mg in 5 mL | 7/7/2023 | |
| Ayurax, LLC | 73308-358 | ORAL | 0.67 mg in 5 mL | 3/4/2021 | |
| Northwind Pharmaceuticals, LLC | 51655-425 | Oral | 2.68 mg in 1 1 | 7/21/2014 | |
| Teva Pharmaceuticals USA, Inc. | 0093-0308 | ORAL | 2.68 mg in 1 1 | 8/14/2021 | |
| New HeightsRx, LLC | 84044-268 | ORAL | 2.68 mg in 1 1 | 5/3/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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