Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats asthma. Sold as Rhinocort, Pulmicort, Rhinocort Allergy, Pulmicort Respules, Entocort Ec and 5 more. Every FDA application for this active ingredient: 11 branded and 21 generic.
As of Nov 14, 2026, FDA lists 32 applications for Budesonide (sold as Rhinocort, Pulmicort, Rhinocort Allergy and others), first approved Feb 14, 1994, with 10 new uses approved and 1 published complete response letter.
First approved: Feb 14, 1994
Applications: 32
New uses approved: 10
Complete response letters: 1
Medicare spending, 2025: $245M
Orphan exclusivity until: Feb 9, 2031
First approved in the EU: Jan 8, 2018
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Cortiment, new approvalA drug with a new route of administration indicated for the treatment of active ulcerative colitis (excluding severe cases). · Ferring Pharmaceuticals Co., Ltd. · Jun 26, 2023
Rectabul, new approvalA drug with a new route of administration indicated for the treatment of ulcerative colitis which is not severe. · EA Pharma Co., Ltd. · Sep 27, 2017
Zentacort, new approvalA drug with a new route of administration indicated for the treatment of mild to moderately active Crohn's disease. · Zeria Pharmaceutical Co., Ltd. · Sep 28, 2016
Pulmicort RespulesDrugs with new additional adult and pediatric (5 years of age and older) dosages for the treatment of bronchial asthma. · AstraZeneca K.K. · Nov 16, 2010
PulmicortDrugs with a new additional pediatric dosage indicated for the treatment of bronchial asthma. · AstraZeneca K.K. · Jul 23, 2010
Clinical Trials
88 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Astrazeneca
Nephron
Aurobindo Pharma USA
Impax Labs Inc
Sandoz
Apotex
Zydus Pharms
Cipla
Lupin
Sun Pharm Inds Inc
Mylan
Eugia Pharma