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Data updated: Nov 8, 2026

LORATADINE AND PSEUDOEPHEDRINE SULFATE (loratadine) · Sun Pharma

Respiratory Approved 2003-01-30
Jump to: Indications Approvals Trials Competitors Safety Patents
8
Indications
--
Phase 3 Trials
23
Years on Market

Details

Status
Over-the-counter
First Approved
2003-01-30
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

Sun Pharma PERRIGO PHARMA INTL BIONPHARMA Dr. Reddy's HERITAGE PHARMA P AND L
Active Ingredient: LORATADINE , PSEUDOEPHEDRINE SULFATE

LORATADINE AND PSEUDOEPHEDRINE SULFATE Approval History

2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
18 FDA actions from 2003 to 2026
Oct 2026 ORIGINAL
Update
Aug 2026 ORIGINAL
Update
May 2024 ORIGINAL
Update

What LORATADINE AND PSEUDOEPHEDRINE SULFATE Treats

8 FDA approvals

Originally approved for its first indication in 2003 . Covers 8 distinct patient populations.

  • Other (8)

Sun Pharma's other novel FDA approvals

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

LEQSELVI
2024
DEURUXOLITINIB PHOSPHATE
1 designation
WINLEVI
2020
CLASCOTERONE
1 designation
📋

Clinical Trial Registry

24 trials
Trial Sponsor ID Phase Status Title
NCT07101445 STUDY00008909 NCI-2025-03018, STUDY00008909 Ph 4 recruiting Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial
NCT05421416 IIT-0020 Ph 2 recruiting Loratadine for the Prevention of G-CSF-related Bone Pain
NCT06019728 SHORTEN results posted LPS17726 U1111-1287-8570 Ph 4 completed A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme
NCT06955741 CN008-0026 Ph 1 completed A Study to Assess Drug Levels, Tolerability and Absolute Biological Availability of Single-dose of BMS-986446 in Healthy Participants
NCT06531707 SIL-30700-III-23(1) Ph 3 completed Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine
NCT05043350 ACUCFPASURHDIRB2020110301REC43 Ph 2, Ph 3 completed Combined Antihistaminics Therapy in COVID 19 Patients
NCT05750875 9669/REG/KEMU/2021 Ph 4 completed Gabapentin Versus Loratadine in Uremic Pruritus
NCT04248712 ATEE results posted 19-005510 Ph 2 terminated Antihistamines in Eosinophilic Esophagitis
NCT02495077 results posted DAIT CTOT-19 U01AI063594, NIAID CRMS ID#: 20678 Ph 2 completed Effects of Inhibiting Early Inflammation in Kidney Transplant Patients
NCT02583594 SCALA TDU14260 2015-002550-12, U1111-1171-7939 Ph 1 completed A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis
NCT03883386 results posted HUM00152719 Ph 2 terminated Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use
NCT02478398 results posted 3641-008 2014-004341-27, MK-3641-008 Ph 3 completed Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008)
NCT02339714 AAMH001 Ph 2 completed Effectivness and Safety of Acupuncture Combined With Moxibustion for Allergic Rhinitis
NCT02513290 QolRhinitis CTBixLo Ph 4 completed Quality of Life in Patients With Allergic Rhinitis: Clinical Trial With Bilastine or Loratadine
NCT03376594 MTU-EC-TM-4-183/57 Ph 2 completed Benjakul Extract and Loratadine for Treatment Allergic Rhinitis Patients
NCT01712009 NOLAN results posted 20110147 Ph 2 completed NOLAN: Naproxen or Loratadine and Neulasta
NCT02576808 MTU-EC-TM-4-077/57 TCTR20151001001 Ph 2 completed Study of Efficacy and Safety of Ginger Extract Compared With Loratadine for Treatment of Allergic Rhinitis
NCT00730912 results posted P05539 Ph 4 completed Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539)
NCT01390441 results posted 8808-002 Ph 1 terminated A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002)
NCT02007434 results posted ATX-101-13-36 Ph 3 completed Patient Experience Study of Deoxycholic Acid Injection
NCT01469234 results posted 18126 PT11-37, P08712 Ph 4 completed A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)
NCT01330017 results posted 18123 CL2010-06, P08156 Ph 2 completed Effects of Phenylephrine on Nasal Congestion in Participants With Seasonal Allergic Rhinitis (P08156 AM2)(Completed)
NCT01413958 results posted 18125 CL2011-06, P08498 Ph 3 completed Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1)
NCT07661459 OAT ICI 114969 Ph 2 recruiting Optimizing Ancillary Therapies With Immune Checkpoint Inhibitors for Solid Tumors (OAT ICI)
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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.

LORATADINE AND PSEUDOEPHEDRINE SULFATE FDA Label Details

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Data Sources

FDA Approval: ANDA076557 → Trials: ClinicalTrials.gov →

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