FDA — authorised 6 January 1960
- Marketing authorisation holder: EASTMAN KODAK
- Status: approved
🇺🇸 Carbocaine in United States
FDA authorised Carbocaine on 6 January 1960
Marketing authorisations
FDA — authorised 17 May 1960
- Application: NDA012250
- Marketing authorisation holder: HOSPIRA
- Local brand name: CARBOCAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 December 1986
- Application: ANDA089408
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 18 March 1992
- Application: ANDA089409
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
FDA — authorised 18 March 1992
- Application: ANDA089406
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
FDA — authorised 8 March 2002
- Application: ANDA089410
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 29 January 2025
- Application: ANDA089407
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
Fresenius Kabi USA was granted marketing authorization by the FDA for Carbocaine on January 29, 2025. Carbocaine is a local anesthetic indicated for use in various medical procedures. The marketing authorization was approved through a standard pathway.
Carbocaine in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Carbocaine approved in United States?
Yes. FDA authorised it on 6 January 1960; FDA authorised it on 17 May 1960; FDA authorised it on 1 December 1986.
Who is the marketing authorisation holder for Carbocaine in United States?
EASTMAN KODAK holds the US marketing authorisation.