FDA — authorised 19 August 1981
- Application: NDA018240
- Marketing authorisation holder: TWI PHARMS
- Local brand name: TENORMIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Rate Control in United States
FDA authorised Rate Control on 19 August 1981 · 1 US adverse-event reports
Marketing authorisations
FDA — authorised 13 September 1989
- Application: NDA019058
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: TENORMIN
- Indication: INJECTABLE — INJECTION
- 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: 23 April 2025 – 23 April 2026
- Total reports: 1
Most-reported reactions
- Neuropathy Peripheral — 1 report (100%)
Other Cardiovascular approved in United States
Frequently asked questions
Is Rate Control approved in United States?
Yes. FDA authorised it on 19 August 1981; FDA authorised it on 13 September 1989.
Who is the marketing authorisation holder for Rate Control in United States?
TWI PHARMS holds the US marketing authorisation.