FDA — authorised 2 August 2005
- Application: ANDA065230
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
🇺🇸 Ceftriaxon in United States
FDA authorised Ceftriaxon on 2 August 2005
Marketing authorisations
FDA — authorised 2 August 2005
- Application: ANDA065231
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 August 2005
- Application: ANDA065232
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 February 2006
- Application: ANDA065245
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 15 February 2006
- Application: ANDA065252
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 May 2006
- Application: ANDA065274
- Marketing authorisation holder: TEVA
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 June 2006
- Application: ANDA065262
- Marketing authorisation holder: TEVA
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 28 February 2007
- Application: ANDA065269
- Marketing authorisation holder: FACTA FARMA
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 February 2007
- Application: ANDA065268
- Marketing authorisation holder: FACTA FARMA
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 15 March 2007
- Application: ANDA065227
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 26 March 2007
- Application: ANDA065294
- Marketing authorisation holder: CEPHAZONE PHARMA
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 10 January 2008
- Application: ANDA065342
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 11 January 2008
- Application: ANDA065305
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 24 July 2008
- Application: ANDA065329
- Marketing authorisation holder: ACS DOBFAR
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 July 2008
- Application: ANDA065328
- Marketing authorisation holder: ACS DOBFAR
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 July 2008
- Application: ANDA065505
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 31 July 2008
- Application: ANDA065504
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 August 2012
- Application: ANDA202563
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 June 2016
- Application: ANDA203702
- Marketing authorisation holder: QILU ANTIBIOTICS
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA
- Status: approved
Ceftriaxon in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Ceftriaxon approved in United States?
Yes. FDA authorised it on 2 August 2005; FDA authorised it on 2 August 2005; FDA authorised it on 2 August 2005.
Who is the marketing authorisation holder for Ceftriaxon in United States?
HOSPIRA INC holds the US marketing authorisation.