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
Marketing authorisations
FDA — authorised 16 April 1986
- Application: NDA019008
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
- 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 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: NDA019005
- Marketing authorisation holder: ABBOTT
- Local brand name: BRETYLIUM TOSYLATE IN DEXTROSE 5%
- 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 14 May 1986
- Application: ANDA070545
- Marketing authorisation holder: HIKMA
- Local brand name: BRETYLIUM TOSYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 May 1986
- Application: ANDA070546
- Marketing authorisation holder: HIKMA
- Local brand name: BRETYLIUM TOSYLATE
- 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
- Status: approved
FDA
- Application: ANDA071151
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: BRETYLIUM TOSYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071152
- Marketing authorisation holder: ASTRAZENECA
- 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
- Application: ANDA071153
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: BRETYLIUM TOSYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA017954
- Marketing authorisation holder: HOSPIRA
- Local brand name: BRETYLOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071181
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: BRETYLIUM TOSYLATE
- Indication: Injectable — Injection
- Status: approved
Bretylium Tosylate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
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.