FDA — authorised 11 February 1987
- Application: NDA050624
- Marketing authorisation holder: HOFFMANN LA ROCHE
- Local brand name: ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Anerning particle in United States
FDA authorised Anerning particle on 11 February 1987
Marketing authorisations
FDA — authorised 23 August 2005
- Application: ANDA065224
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: CEFTRIAXONE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 January 2017
- Application: ANDA091117
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: CEFTRIAXONE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Anerning particle 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 Anerning particle approved in United States?
Yes. FDA authorised it on 11 February 1987; FDA authorised it on 23 August 2005; FDA authorised it on 20 January 2017.
Who is the marketing authorisation holder for Anerning particle in United States?
HOFFMANN LA ROCHE holds the US marketing authorisation.