FDA — authorised 6 March 1986
- Application: ANDA070119
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: BRETYLIUM TOSYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 BRETYLIUM TOSYLATE in United States
FDA authorised BRETYLIUM TOSYLATE on 6 March 1986 · 2 US adverse-event reports
Marketing authorisations
FDA — authorised 16 April 1986
- Application: NDA019033
- Marketing authorisation holder: HOSPIRA
- Local brand name: BRETYLIUM TOSYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 April 1986
- Application: NDA019030
- Marketing authorisation holder: HOSPIRA
- Local brand name: BRETYLIUM TOSYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 April 1986
- Application: NDA019121
- Marketing authorisation holder: B BRAUN
- Local brand name: BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 December 2018
- Application: ANDA204386
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: BRETYLIUM TOSYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070134
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: BRETYLIUM TOSYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071298
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: BRETYLIUM TOSYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
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: 2
Most-reported reactions
- Drug Ineffective — 1 report (50%)
- No Adverse Event — 1 report (50%)
BRETYLIUM TOSYLATE 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 BRETYLIUM TOSYLATE approved in United States?
Yes. FDA authorised it on 6 March 1986; FDA authorised it on 16 April 1986; FDA authorised it on 16 April 1986.
Who is the marketing authorisation holder for BRETYLIUM TOSYLATE in United States?
INTL MEDICATION holds the US marketing authorisation.