FDA — authorised 16 June 2017
- Application: ANDA206409
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ELETRIPTAN HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 ELETRIPTAN HYDROBROMIDE in United States
FDA authorised ELETRIPTAN HYDROBROMIDE on 16 June 2017 · 518 US adverse-event reports
Marketing authorisations
FDA — authorised 11 August 2017
- Application: ANDA205152
- Marketing authorisation holder: MYLAN
- Local brand name: ELETRIPTAN HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 August 2017
- Application: ANDA205186
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ELETRIPTAN HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 May 2018
- Application: ANDA206787
- Marketing authorisation holder: STEVENS J
- Local brand name: ELETRIPTAN HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2019
- Application: ANDA210708
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ELETRIPTAN HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 2020
- Application: ANDA209680
- Marketing authorisation holder: CARLSBAD
- Local brand name: ELETRIPTAN HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 2022
- Application: ANDA215467
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: ELETRIPTAN HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA201536
- Marketing authorisation holder: APOTEX INC
- Local brand name: ELETRIPTAN HYDROBROMIDE
- Indication: TABLET — ORAL
- 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: 518
Most-reported reactions
- Drug Ineffective — 114 reports (22.01%)
- Headache — 77 reports (14.86%)
- Nausea — 54 reports (10.42%)
- Migraine — 52 reports (10.04%)
- Pain — 51 reports (9.85%)
- Off Label Use — 40 reports (7.72%)
- Vomiting — 37 reports (7.14%)
- Paraesthesia — 36 reports (6.95%)
- Anxiety — 29 reports (5.6%)
- Fatigue — 28 reports (5.41%)
ELETRIPTAN HYDROBROMIDE 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 ELETRIPTAN HYDROBROMIDE approved in United States?
Yes. FDA authorised it on 16 June 2017; FDA authorised it on 11 August 2017; FDA authorised it on 29 August 2017.
Who is the marketing authorisation holder for ELETRIPTAN HYDROBROMIDE in United States?
ZYDUS PHARMS holds the US marketing authorisation.