FDA — authorised 4 March 2014
- Application: ANDA078193
- Marketing authorisation holder: TEVA PHARMS USA
- Status: supplemented
🇺🇸 RALOXIFENE HYDROCHLORIDE in United States
FDA authorised RALOXIFENE HYDROCHLORIDE on 4 March 2014 · 412 US adverse-event reports
Marketing authorisations
FDA — authorised 24 September 2014
- Application: ANDA090842
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: RALOXIFENE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 January 2015
- Application: ANDA200825
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: RALOXIFENE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 2015
- Application: ANDA204310
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: supplemented
FDA — authorised 22 March 2016
- Application: ANDA204491
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: RALOXIFENE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 2016
- Application: ANDA208206
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: RALOXIFENE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 October 2016
- Application: ANDA206384
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: RALOXIFENE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 August 2020
- Application: ANDA211324
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: RALOXIFENE HYDROCHLORIDE
- 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: 412
Most-reported reactions
- Fall — 55 reports (13.35%)
- Arthralgia — 49 reports (11.89%)
- Fatigue — 48 reports (11.65%)
- Nausea — 45 reports (10.92%)
- Back Pain — 40 reports (9.71%)
- Diarrhoea — 38 reports (9.22%)
- Headache — 36 reports (8.74%)
- Pain — 35 reports (8.5%)
- Asthenia — 33 reports (8.01%)
- Dizziness — 33 reports (8.01%)
RALOXIFENE HYDROCHLORIDE 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 RALOXIFENE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 4 March 2014; FDA authorised it on 24 September 2014; FDA authorised it on 21 January 2015.
Who is the marketing authorisation holder for RALOXIFENE HYDROCHLORIDE in United States?
TEVA PHARMS USA holds the US marketing authorisation.