FDA — authorised 18 November 1965
- Application: NDA021382
- Marketing authorisation holder: DENTSPLY PHARM
- Local brand name: CITANEST PLAIN DENTAL
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 PRILOCAINE HYDROCHLORIDE in United States
FDA authorised PRILOCAINE HYDROCHLORIDE on 18 November 1965
Marketing authorisations
FDA — authorised 29 September 2010
- Application: ANDA079235
- Marketing authorisation holder: SEPTODONT INC
- Local brand name: PRILOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
PRILOCAINE 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 PRILOCAINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 18 November 1965; FDA authorised it on 29 September 2010; FDA has authorised it.
Who is the marketing authorisation holder for PRILOCAINE HYDROCHLORIDE in United States?
DENTSPLY PHARM holds the US marketing authorisation.