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BECLOMETHASONE DIPROPIONATE ›
Regulatory · United States
Marketing authorisations
FDA — authorised 12 May 1976
Application: NDA017573
Marketing authorisation holder: SCHERING
Local brand name: VANCERIL
Indication: AEROSOL, METERED — INHALATION
Status: approved
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FDA — authorised 15 September 2000
Application: NDA020911
Marketing authorisation holder: TEVA BRANDED PHARM
Local brand name: QVAR 40
Indication: AEROSOL, METERED — INHALATION
Status: approved
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FDA — authorised 16 December 2025
Application: ANDA213811
Marketing authorisation holder: AMNEAL IRELAND LTD
Status: approved
FDA
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Window: 20 April 2025 – 20 April 2026
Total reports: 3,390
Most-reported reactions
Dyspnoea — 588 reports (17.35%) Asthma — 358 reports (10.56%) Diarrhoea — 358 reports (10.56%) Vomiting — 330 reports (9.73%) Nausea — 326 reports (9.62%) Pneumonia — 306 reports (9.03%) Fatigue — 302 reports (8.91%) Malaise — 297 reports (8.76%) Headache — 277 reports (8.17%) Dizziness — 248 reports (7.32%)
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BECLOMETHASONE DIPROPIONATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is BECLOMETHASONE DIPROPIONATE approved in United States?
Yes. FDA authorised it on 12 May 1976; FDA authorised it on 15 September 2000; FDA authorised it on 16 December 2025.
Who is the marketing authorisation holder for BECLOMETHASONE DIPROPIONATE in United States?
SCHERING holds the US marketing authorisation.