FDA — authorised 18 August 2003
- Application: ANDA076453
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: LIDOCAINE AND PRILOCAINE
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 lidocaine and prilocaine in United States
FDA authorised lidocaine and prilocaine on 18 August 2003
Marketing authorisations
FDA — authorised 27 August 2003
- Application: ANDA076320
- Marketing authorisation holder: ENCUBE
- Local brand name: LIDOCAINE AND PRILOCAINE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 25 September 2003
- Application: ANDA076290
- Marketing authorisation holder: HIKMA
- Local brand name: LIDOCAINE AND PRILOCAINE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 29 June 2018
- Application: ANDA205887
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: LIDOCAINE AND PRILOCAINE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 21 September 2020
- Application: ANDA213253
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: LIDOCAINE AND PRILOCAINE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 27 July 2021
- Application: ANDA212482
- Marketing authorisation holder: PADAGIS US
- Local brand name: LIDOCAINE AND PRILOCAINE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 8 April 2022
- Application: ANDA213923
- Marketing authorisation holder: ALEMBIC
- Local brand name: LIDOCAINE AND PRILOCAINE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 17 December 2024
- Application: ANDA219120
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Status: approved
FDA
- Status: approved
lidocaine and prilocaine 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 and prilocaine approved in United States?
Yes. FDA authorised it on 18 August 2003; FDA authorised it on 27 August 2003; FDA authorised it on 25 September 2003.
Who is the marketing authorisation holder for lidocaine and prilocaine in United States?
FOUGERA PHARMS holds the US marketing authorisation.