Betamethasone

Sold as Celestone. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 3 applications for Betamethasone (sold as Celestone), first approved Apr 17, 1961, with 0 new uses approved and 0 published complete response letters.

First approved: Apr 17, 1961
Applications: 3
New uses approved: 0
Complete response letters: 0

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of Ataxia Telangiectasia.Acasti Pharma Inc. · designated Oct 7, 2015

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

RinderonDrugs with a new additional indication and a new dosage for prevention of neonatal respiratory distress syndrome by way of enhancing fetal lung maturation… · Shionogi & Co., Ltd. · Nov 6, 2009

Clinical Trials

75 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


An Exploratory Study of Single-Dose Neoadjuvant Nivolumab Without Surgical Delay in Patients With Resectable HCCHepato Cellular Carcinoma (HCC), Immune Checkpoint Inhibitor · National Taiwan University Hospital	Phase 2	Not yet recruiting	Oct 28, 2026
A Study of Standard of Care Drugs With or Without Ivermectin for Daraxonrasib-Induced Skin Toxicity in People With Pancreatic CancerPancreatic Cancer, Skin Toxicities · Memorial Sloan Kettering Cancer Center	Phase 2	Recruiting	Oct 26, 2026
Effects of Injection Combined With Spencer Technique on Painful Frozen ShoulderFrozen Shoulder · Zichao Zhang	Not applicable	Active, not recruiting	Oct 19, 2026
Transconjunctival Versus Transcutaneous Betamethasone for Upper Eyelid Retraction in TEDThyroid Eye Disease · Assiut University	Not applicable	Not yet recruiting	Oct 8, 2026
Transdermal Versus Intralesional Betamethasone for KeloidsKeloid · First Hospital of China Medical University	Not applicable	Active, not recruiting	Sep 23, 2026
Comparing Three Epidural Steroid Injection Approaches for Lumbar Radicular PainLumbar Disc Herniation, Lumbosacral Radiculopathy · Benha University	Phase 4	Not yet recruiting	Sep 10, 2026
Success Rates and Safety of Steroid Injections in Managing Spinal and Sacro-Iliac Pain (CORTisone Injection Spine Study)Back Pain Lower Back, Neck Pain · Igor Wilderman. MD	Phase 4	Recruiting	Aug 13, 2026
Azithromycin in Atopic DermatitisAtopic Dermatitis · Cairo University	Phase 4	Not yet recruiting	Jul 20, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Apr 17, 1961	CelestoneNDA 12657 · New molecular entity	Schering	17	Discontinued
Apr 13, 1964	CelestoneNDA 14215 · New dosage form	Merck Sharp Dohme	18	Discontinued
—	CelestoneNDA 14762	Schering	0	Discontinued

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