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Data updated: Nov 8, 2026

DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR (desloratadine) · Dr. Reddy's

Respiratory Approved 2011-04-26
FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
15
Years on Market

Details

Status
Prescription
First Approved
2011-04-26
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

Dr. Reddy's
Active Ingredient: DESLORATADINE , PSEUDOEPHEDRINE SULFATE

DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR Approval History

2012
2013
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2015
2016
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2018
2019
2020
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2022
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2024
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2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2011 to 2011
Apr 2011 ORIGINAL
Update
FDA Letter

What DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR Treats

1 FDA approvals

Originally approved for its first indication in 2011 .

  • Other (1)

DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

1

Same target(s), different indications — where else is this mechanism being explored?

QUZYTTIR
ESTEVE
2019 1 indic.

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

15 trials
Trial Sponsor ID Phase Status Title
NCT07566351 MDP.26.03.216 Ph 2 recruiting Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis
NCT07486583 MD-142-2025 Ph 3 not yet recruiting Autologous Whole Blood Therapy in Chronic Idiopathic Urticaria Patients.
NCT07333716 UC 12/2025 TRop1 Ph 2 recruiting Desloratadine in Patients With Ulcerative Colitis
NCT05214911 DESPRED EF177 Ph 3 completed Fixed Dose Combination of Desloratadine / Prednisolone in the Treatment of Moderate Severe Allergic Rhinitis in Children
NCT06916884 DESCUBRA SIL-30810-III-23(1) Ph 3 completed Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine
NCT01916967 results posted 4117-201 132243 Ph 3 completed An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)
NCT02646020 EGFR-TKIs TAPE001 Ph 2 completed Aprepitant vs. Desloratadine in EGFR-TKIs Related Pruritus Treatment
NCT02507635 535 Ph 4 completed Anti-inflammatory H1 Antihistamines Allergic Rhinitis
NCT01985789 PHPY2013/14 Ph 4 completed Anti-histamines and Methacholine Challenges.
NCT01400828 YCD159 Ph 3 completed Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis
NCT01940393 GACE-01 Ph 4 completed Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria
NCT01444196 AECUDATT 2008-005746-22 2008-005746-22 Ph 4 completed Desloratadine 5, 10 and 20mg in Patients With Cold Urticaria
NCT07821320 Endometriose0926 Ph 2 not yet recruiting Impact of the Antihistamine Desloratadine on the Quality of Life and Dysmenorrhea in Patients With Endometriosis
NCT07836712 0C-26-9 NCI-2026-06680, 0C-26-9 Ph 2 not yet recruiting Multiple Adjunct Therapies to Improve Immunotherapy Treatment in Patients With Locally Advanced or Metastatic Melanoma or Advanced Hepatocellular Cancer
NCT07835074 DESPRIN DEP114-III-0226 Ph 3 not yet recruiting A Study to Evaluate DEP114 for the Treatment of Acute Exacerbation of Persistent Allergic Rhinitis in Children Aged 6 to Under 12 Years
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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.

DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR FDA Label Details

FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →

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Data Sources

FDA Approval: ANDA078366 → Trials: ClinicalTrials.gov →

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