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Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

BUDESONIDE

BUDESONIDE Corticosteroid Hormone Receptor Agonists
Respiratory Approved 2008-11-18
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
21
Indications
--
Phase 3 Trials
17
Years on Market

Details

Status
Prescription
First Approved
2008-11-18
Routes
INHALATION, ORAL, RECTAL, NASAL
Dosage Forms
SUSPENSION, CAPSULE, DELAYED RELEASE, TABLET, EXTENDED RELEASE, AEROSOL, FOAM, SPRAY, METERED

Companies

Teva Cipla EUGIA PHARMA Aurobindo Pharma Novartis Viatris PADAGIS ISRAEL NEPHRON IMPAX LABS INC SCIECURE PHARMA INC Apotex ZYDUS PHARMS Dr. Reddy's RISING AMNEAL PHARMS NATCO Lupin Sun Pharma
Active Ingredient: BUDESONIDE

BUDESONIDE Approval History

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What BUDESONIDE Treats

5 indications

BUDESONIDE is approved for 5 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hay Fever
  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing
Source: FDA Label

Drugs Similar to BUDESONIDE

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ADVAIR DISKUS 100/50
FLUTICASONE PROPIONATE
5 shared
GSK
Shared indications:
Hay FeverNasal CongestionItchy Nose +2 more
ADVAIR DISKUS 250/50
FLUTICASONE PROPIONATE
5 shared
GSK
Shared indications:
Hay FeverNasal CongestionItchy Nose +2 more
ADVAIR DISKUS 500/50
FLUTICASONE PROPIONATE
5 shared
GSK
Shared indications:
Hay FeverNasal CongestionItchy Nose +2 more
ASTEPRO
AZELASTINE HYDROCHRLORIDE
5 shared
MEDA PHARMS
Shared indications:
Hay FeverNasal CongestionRunny Nose +2 more
BREZTRI AEROSPHERE
BUDESONIDE
5 shared
AstraZeneca
Shared indications:
Hay FeverNasal CongestionRunny Nose +2 more
ENTOCORT EC
BUDESONIDE
5 shared
PADAGIS US
Shared indications:
Hay FeverNasal CongestionRunny Nose +2 more
FLOVENT DISKUS 100
FLUTICASONE PROPIONATE
5 shared
GSK
Shared indications:
Hay FeverNasal CongestionItchy Nose +2 more
FLOVENT DISKUS 250
FLUTICASONE PROPIONATE
5 shared
GSK
Shared indications:
Hay FeverNasal CongestionItchy Nose +2 more
FLOVENT DISKUS 50
FLUTICASONE PROPIONATE
5 shared
GSK
Shared indications:
Hay FeverNasal CongestionItchy Nose +2 more
FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE
5 shared
ENCUBE
Shared indications:
Hay FeverNasal CongestionItchy Nose +2 more
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
FLUTICASONE PROPIONATE
5 shared
Teva
Shared indications:
Hay FeverNasal CongestionItchy Nose +2 more
RHINOCORT
BUDESONIDE
5 shared
KENVUE BRANDS
Shared indications:
Hay FeverNasal CongestionRunny Nose +2 more
SYMBICORT AEROSPHERE
BUDESONIDE
5 shared
AstraZeneca
Shared indications:
Hay FeverNasal CongestionRunny Nose +2 more
IMMPHENTIV
PHENYLEPHRINE HYDROCHLORIDE
3 shared
Hikma
Shared indications:
Nasal CongestionRunny NoseSneezing
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
3 shared
GENUS
Shared indications:
Nasal CongestionRunny NoseSneezing
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
3 shared
Dr. Reddy's
Shared indications:
Nasal CongestionRunny NoseSneezing
VELTANE
BROMPHENIRAMINE MALEATE
3 shared
LANNETT
Shared indications:
Runny NoseSneezingHay Fever
KOVANAZE
OXYMETAZOLINE HYDROCHLORIDE
2 shared
ST RENATUS
Shared indications:
Nasal CongestionHay Fever
AMMONIUM CHLORIDE IN PLASTIC CONTAINER
AMMONIUM CHLORIDE
1 shared
Pfizer
Shared indications:
Hay Fever
CLARINEX-D 12 HOUR
DESLORATADINE
1 shared
Merck
Shared indications:
Nasal Congestion
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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.

BUDESONIDE FDA Label Details

Pro

Indications & Usage

Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • itchy nose • sneezing

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Data Sources

FDA Approval: ANDA077519 → Label: DailyMed → Trials: ClinicalTrials.gov →

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