FDA — authorised 28 September 1972
- Application: ANDA080408
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Lidocaine Hydrochloride Preservative Free in United States
FDA authorised Lidocaine Hydrochloride Preservative Free on 28 September 1972 · 10 US adverse-event reports
Marketing authorisations
FDA — authorised 16 June 1975
- Application: ANDA084625
- Marketing authorisation holder: HIKMA
- Local brand name: LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 March 1976
- Application: NDA017584
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 December 1976
- Application: NDA017702
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 May 1984
- Application: ANDA088295
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 February 2003
- Application: ANDA040433
- Marketing authorisation holder: SENTISS
- Status: approved
FDA — authorised 27 September 2010
- Application: ANDA090665
- Marketing authorisation holder: EXTROVIS
- Local brand name: LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 March 2013
- Application: ANDA203040
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 March 2013
- Application: ANDA203082
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 April 2018
- Application: ANDA208017
- Marketing authorisation holder: SPECTRA MDCL DEVICES
- Status: approved
FDA — authorised 29 October 2019
- Application: ANDA201094
- Marketing authorisation holder: SAGENT PHARMS INC
- Indication: Labeling
- Status: approved
FDA — authorised 8 June 2021
- Application: ANDA088389
- Marketing authorisation holder: DEPROCO
- Indication: Labeling
- Status: approved
FDA — authorised 23 March 2022
- Application: ANDA216250
- Marketing authorisation holder: NOVITIUM PHARMA
- 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: 19 April 2025 – 19 April 2026
- Total reports: 10
Most-reported reactions
- Feeling Hot — 2 reports (20%)
- Oedema Peripheral — 2 reports (20%)
- Asthenia — 1 report (10%)
- Chest Discomfort — 1 report (10%)
- Injection Site Erythema — 1 report (10%)
- Injection Site Swelling — 1 report (10%)
- Malaise — 1 report (10%)
- Nervousness — 1 report (10%)
Lidocaine Hydrochloride Preservative Free 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 Lidocaine Hydrochloride Preservative Free approved in United States?
Yes. FDA authorised it on 28 September 1972; FDA authorised it on 16 June 1975; FDA authorised it on 26 March 1976.
Who is the marketing authorisation holder for Lidocaine Hydrochloride Preservative Free in United States?
HOSPIRA holds the US marketing authorisation.