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Uceris

(Budesonide 200)

Small molecule

0

Indications

1

Total Trials

0

Active Trials

0

Competitors

11

FDA Applications

NDA/BLA/ANDA regulatory filings

Clinical

Trials by Indication[1]

Acute Mountain Sickness1 trial

Inhaled Budesonide and Acute Mountain Sickness

Completed·SSalzburger Landeskliniken·Phase 1·NCT02811016·51 enrolled

Regulatory

FDA Approval Timeline[3]

Feb 14, 1994

RHINOCORT

NDA NDA020233

Jun 24, 1997

PULMICORT

NDA NDA020441

Aug 8, 2000

PULMICORT RESPULES

NDA NDA020929

Oct 2, 2001

ENTOCORT EC

NDA NDA021324

Jul 12, 2006

PULMICORT FLEXHALER

NDA NDA021949

Jan 14, 2013

UCERIS

NDA NDA203634

Oct 7, 2014

UCERIS

NDA NDA205613

Mar 23, 2015

RHINOCORT ALLERGY

NDA NDA020746

Jun 13, 2019

ORTIKOS

NDA NDA211929

Dec 15, 2021

TARPEYO

NDA NDA215935

Feb 9, 2024

EOHILIA

NDA NDA213976

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Budesonide 200. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Budesonide 200 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA213976). U.S. Food & Drug Administration.
[4]
SEC EDGAR — Salix company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: SSalix

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