Overview
Loratadine is a second generation antihistamine used to manage symptoms of allergic rhinitis. A lack of sedative and CNS adverse effects make loratadine, along with other second generation antihistamines, preferable over their 1st generation counterparts in many clinical situations.
Background
Loratadine is a second generation antihistamine used to manage symptoms of allergic rhinitis. A lack of sedative and CNS adverse effects make loratadine, along with other second generation antihistamines, preferable over their 1st generation counterparts in many clinical situations.
Indication
Loratadine is a 2nd generation antihistamine and is used to manage symptoms of allergic rhinitis, wheal formation, urticaria, and other allergic dermatologic conditions.
Associated Conditions
- Allergic Dermatologic Disorders
- Allergic Reaction
- Allergic Rhinitis (AR)
- Allergy to Tree Pollen
- Chronic Urticaria
- Common Cold
- Epiphora
- Eye pruritus
- Fever
- Nasal Congestion
- Nasal Itching
- Pain
- Perennial Allergic Rhinitis (PAR)
- Pruritus
- Rhinitis Perennial
- Rhinorrhoea
- Seasonal Allergic Rhinitis
- Sneezing
- Sensation of burning in the eyes
- Watery itchy eyes
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/02 | Phase 1 | Recruiting | |||
2024/08/01 | Phase 3 | Recruiting | |||
2024/02/09 | Phase 4 | Not yet recruiting | Hangzhou Grand Biologic Pharmaceutical, Inc. | ||
2024/01/22 | Phase 4 | Recruiting | |||
2023/08/31 | Phase 4 | Completed | |||
2023/03/02 | Phase 4 | Completed | |||
2022/06/16 | Phase 2 | Recruiting | |||
2022/03/04 | Phase 4 | Completed | Andover Research Eye Institute | ||
2022/02/17 | Phase 3 | UNKNOWN | |||
2022/01/13 | Phase 2 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Amazon.com Services LLC | 72288-511 | ORAL | 5 mg in 5 mL | 5/12/2025 | |
| Meijer Distribution Inc | 41250-629 | ORAL | 5 mg in 1 1 | 5/7/2025 | |
| Meijer Distribution Inc | 41250-954 | ORAL | 5 mg in 1 1 | 5/28/2025 | |
| Lannett Company, Inc. | 54838-558 | ORAL | 5 mg in 5 mL | 6/19/2025 | |
| Granules Pharmaceuticals Inc. | 70010-162 | ORAL | 10 mg in 1 1 | 5/5/2025 | |
| United Natural Foods, Inc. dba UNFI | 41163-633 | ORAL | 5 mg in 5 mL | 5/7/2025 | |
| CVS Pharmacy, Inc. | 69842-242 | ORAL | 10 mg in 1 1 | 5/13/2025 | |
| Northwind Pharmaceuticals, LLC | 51655-027 | ORAL | 10 mg in 1 1 | 10/31/2014 | |
| WinCo Foods, LLC | 67091-350 | ORAL | 10 mg in 1 1 | 4/8/2025 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-0557 | ORAL | 5 mg in 5 mL | 5/12/2025 |
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 |
|---|---|---|---|---|---|
| RINITYN TABLET 10 mg | SIN12067P | TABLET | 10.00 mg | 9/12/2002 | |
| SUNADINE TABLET 10MG | SIN14482P | TABLET, FILM COATED | 10mg | 1/15/2014 | |
| LORIDIN RAPITAB 10 mg | SIN12029P | TABLET | 10 mg | 7/19/2002 | |
| CLARITYN-D 24HOUR EXTENDED RELEASE TABLET | SIN12246P | TABLET, SUGAR COATED | 10 mg | 4/1/2003 | |
| LORFAST TABLET 10 mg | SIN11679P | TABLET | 10 mg | 9/24/2001 | |
| CLARITYNE TABLET 10mg | SIN14077P | TABLET, FILM COATED | 10mg | 1/12/2012 | |
| CLARITYNE SYRUP 5 MG/5 ML (GRAPE FLAVOR) | SIN16091P | SYRUP | 5 mg/ 5mL | 1/29/2021 | |
| HALODIN TABLETS 10 mg | SIN10351P | TABLET | 10 mg | 11/4/1998 | |
| Loradine Tablet 10 mg | SIN13341P | TABLET | 10.0 mg | 8/27/2007 | |
| EZEDE' TABLET 10 mg | SIN11932P | TABLET | 10 mg | 5/14/2002 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Loratadine Granules | 国药准字H20041708 | 化学药品 | 颗粒剂 | 6/15/2020 | |
| Loratadine Granules | 国药准字H20041015 | 化学药品 | 颗粒剂 | 7/28/2020 | |
| Loratadine Granules | 国药准字H20040439 | 化学药品 | 颗粒剂 | 6/5/2020 | |
| Loratadine Granules | 国药准字H20060719 | 化学药品 | 颗粒剂 | 5/20/2020 | |
| Loratadine Orally Disintegrating Tablets | 国药准字H20080294 | 化学药品 | 片剂 | 1/3/2023 | |
| Loratadine Orally Disintegrating Tablets | 国药准字H20080190 | 化学药品 | 片剂 | 11/10/2022 | |
| Loratadine Orally Disintegrating Tablets | 国药准字H20080527 | 化学药品 | 片剂 | 7/7/2023 | |
| Loratadine Orally Disintegrating Tablets | 国药准字H20080305 | 化学药品 | 片剂 | 5/8/2023 | |
| Loratadine Orally Disintegrating Tablets | 国药准字H20070300 | 化学药品 | 片剂 | 7/26/2022 | |
| Loratadine Capsules | 国药准字H20163238 | 化学药品 | 胶囊剂 | 4/30/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ROTIFAR TAB 10MG | N/A | wings pharmaceutical ltd | N/A | N/A | 8/9/2004 |
| LORSEDIN TABLETS 10MG | N/A | N/A | N/A | 12/8/2011 | |
| LORATADINE NON-DROWSY TAB 10MG | N/A | N/A | N/A | 12/24/2010 | |
| CLARIN TAB 10MG | N/A | N/A | N/A | 7/14/2005 | |
| ALLERGONE CAP 10MG | N/A | N/A | N/A | 9/10/2005 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| AMCAL LORATADINE 10 mg tablets blister pack | 226844 | Medicine | A | 8/12/2014 | |
| TRUST LORATADINE ANTIHISTAMINE loratadine 10 mg tablets bottle pack | 312388 | Medicine | A | 12/11/2018 | |
| APOHEALTH LORATADINE HAYFEVER & ALLERGY RELIEF loratadine 10 mg tablets blister pack | 227277 | Medicine | A | 8/26/2014 | |
| CLARATYNE-D WITH DECONGESTANT tablets blister pack | 53516 | Medicine | A | 9/21/1995 | |
| CLARATYNE loratadine 10mg tablet blister pack (general sale) | 200430 | Medicine | A | 8/28/2012 | |
| CHILDREN'S CLARATYNE loratadine 1 mg/mL grape flavour oral liquid solution bottle (reformulation 2) | 384266 | Medicine | A | 2/18/2022 | |
| Allervic Chewables - Bubblegum Flavour | 396098 | Medicine | A | 9/19/2022 | |
| CLARATYNE REDITABS loratadine 10 mg orally disintegrating tablet blister pack (general sale) | 279809 | Medicine | A | 8/31/2016 | |
| TRUST LORATADINE 10 mg tablet blister pack | 161830 | Medicine | A | 5/15/2009 | |
| PHARMACY CHOICE LORATADINE TABLETS loratadine 10 mg tablet blister pack | 379604 | Medicine | A | 11/30/2021 |