FDA — authorised 4 December 1973
- Application: ANDA083559
- Marketing authorisation holder: BELMORA LLC
- Local brand name: MEPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 MEPIVACAINE HYDROCHLORIDE in United States
FDA authorised MEPIVACAINE HYDROCHLORIDE on 4 December 1973 · 177 US adverse-event reports
Marketing authorisations
FDA — authorised 17 December 1975
- Application: ANDA084777
- Marketing authorisation holder: SOLVAY
- Local brand name: ARESTOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 October 1982
- Application: ANDA087509
- Marketing authorisation holder: INTL MEDICATION SYS
- Local brand name: MEPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 August 1984
- Application: ANDA088653
- Marketing authorisation holder: DENTSPLY PHARM
- Local brand name: POLOCAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 October 1984
- Application: ANDA088387
- Marketing authorisation holder: DEPROCO
- Local brand name: SCANDONEST PLAIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 November 1984
- Application: ANDA088770
- Marketing authorisation holder: WATSON LABS
- Local brand name: MEPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 November 1984
- Application: ANDA088769
- Marketing authorisation holder: WATSON LABS
- Local brand name: MEPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 December 1986
- Application: ANDA089408
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: POLOCAINE-MPF
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 December 1986
- Application: ANDA089406
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: POLOCAINE-MPF
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 December 1986
- Application: ANDA089407
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: POLOCAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 December 1986
- Application: ANDA089409
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: POLOCAINE-MPF
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 December 1986
- Application: ANDA089410
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: POLOCAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 April 2008
- Application: ANDA040806
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: MEPIVACAINE HYDROCHLORIDE
- 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: 177
Most-reported reactions
- Dyspnoea — 24 reports (13.56%)
- Hypotension — 22 reports (12.43%)
- Nausea — 22 reports (12.43%)
- Dizziness — 19 reports (10.73%)
- Pruritus — 18 reports (10.17%)
- Drug Ineffective — 16 reports (9.04%)
- Monoplegia — 16 reports (9.04%)
- Bradycardia — 14 reports (7.91%)
- Arthralgia — 13 reports (7.34%)
- Syncope — 13 reports (7.34%)
MEPIVACAINE 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 MEPIVACAINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 4 December 1973; FDA authorised it on 17 December 1975; FDA authorised it on 5 October 1982.
Who is the marketing authorisation holder for MEPIVACAINE HYDROCHLORIDE in United States?
BELMORA LLC holds the US marketing authorisation.