FDA — authorised 5 May 1987
- Application: NDA019350
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: CUPRIC SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 CUPRIC SULFATE in United States
FDA authorised CUPRIC SULFATE on 5 May 1987 · 534 US adverse-event reports
Marketing authorisations
FDA — authorised 2 July 2020
- Application: NDA209376
- Marketing authorisation holder: AM REGENT
- Local brand name: MULTRYS
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 16 December 2022
- Application: ANDA216324
- Marketing authorisation holder: AM REGENT
- Local brand name: CUPRIC SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 August 2024
- Application: ANDA218745
- Marketing authorisation holder: APOTEX CORP
- Local brand name: CUPRIC SULFATE
- 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: 534
Most-reported reactions
- Pulmonary Embolism — 72 reports (13.48%)
- Full Blood Count Abnormal — 54 reports (10.11%)
- Condition Aggravated — 53 reports (9.93%)
- Dyspnoea — 53 reports (9.93%)
- Asthma — 51 reports (9.55%)
- Haemoptysis — 51 reports (9.55%)
- Anxiety — 50 reports (9.36%)
- Eosinophilic Granulomatosis With Polyangiitis — 50 reports (9.36%)
- Hypothyroidism — 50 reports (9.36%)
- Neuritis — 50 reports (9.36%)
CUPRIC SULFATE 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 CUPRIC SULFATE approved in United States?
Yes. FDA authorised it on 5 May 1987; FDA authorised it on 2 July 2020; FDA authorised it on 16 December 2022.
Who is the marketing authorisation holder for CUPRIC SULFATE in United States?
ABRAXIS PHARM holds the US marketing authorisation.