FDA — authorised 30 March 2006
- Application: NDA020971
- Marketing authorisation holder: DEPROCO
- Indication: Labeling
- Status: approved
🇺🇸 Septocaine in United States
FDA authorised Septocaine on 30 March 2006
Marketing authorisations
FDA — authorised 10 March 2014
- Application: NDA022466
- Marketing authorisation holder: PIERREL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 15 August 2025
- Application: NDA218643
- Marketing authorisation holder: AM GENOMICS
- Indication: Type 3 - New Dosage Form and Type 4 - New Combination
- Status: approved
The FDA approved Septocaine, a local anesthetic, for a new dosage form and combination. This approval was granted to AM GENOMICS on 15 August 2025, under the application number NDA218643. The approval was for Type 3 - New Dosage Form and Type 4 - New Combination indications.
Septocaine in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Septocaine approved in United States?
Yes. FDA authorised it on 30 March 2006; FDA authorised it on 10 March 2014; FDA authorised it on 15 August 2025.
Who is the marketing authorisation holder for Septocaine in United States?
DEPROCO holds the US marketing authorisation.