FDA — authorised 21 December 1984
- Application: NDA050585
- Marketing authorisation holder: HOFFMANN LA ROCHE
- Local brand name: ROCEPHIN
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
🇺🇸 Rocephin in United States
FDA authorised Rocephin on 21 December 1984
Marketing authorisations
FDA — authorised 30 April 1987
- Application: ANDA062654
- Marketing authorisation holder: HOFFMANN LA ROCHE
- Local brand name: ROCEPHIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 August 1993
- Application: ANDA063239
- Marketing authorisation holder: HOFFMANN LA ROCHE
- Local brand name: ROCEPHIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 September 2003
- Application: ANDA065125
- Marketing authorisation holder: LUPIN
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 9 May 2005
- Application: ANDA065169
- Marketing authorisation holder: SANDOZ
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 17 May 2005
- Application: ANDA065168
- Marketing authorisation holder: SANDOZ
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 August 2005
- Application: ANDA065230
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- 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 2 August 2005
- Application: ANDA065231
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INJECTION
- 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 15 February 2006
- Application: ANDA065245
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 1 May 2006
- Application: ANDA065274
- Marketing authorisation holder: TEVA
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 May 2006
- Application: ANDA065180
- Marketing authorisation holder: APOTEX
- 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 12 September 2006
- Application: ANDA065263
- Marketing authorisation holder: LUPIN
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INJECTION
- 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 12 April 2007
- Application: ANDA065391
- Marketing authorisation holder: WOCKHARDT BIO AG
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 22 October 2007
- Application: ANDA065224
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Labeling
- 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: ANDA065328
- Marketing authorisation holder: ACS DOBFAR
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INJECTION
- 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 31 July 2008
- Application: ANDA065504
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- 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 14 January 2009
- Application: ANDA065204
- Marketing authorisation holder: SANDOZ INC
- Indication: Labeling
- 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 — authorised 17 October 2018
- Application: ANDA209218
- Marketing authorisation holder: QILU ANTIBIOTICS
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 September 2020
- Application: NDA050796
- Marketing authorisation holder: B BRAUN
- Indication: Labeling
- Status: approved
FDA — authorised 12 January 2024
- Application: ANDA210197
- Marketing authorisation holder: DEVA HOLDING AS
- Local brand name: CEFTRIAXONE
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA
- Application: ANDA062510
- Marketing authorisation holder: ROCHE
- Local brand name: ROCEPHIN
- Indication: INJECTABLE — INJECTION
- Status: approved
Rocephin 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 Rocephin approved in United States?
Yes. FDA authorised it on 21 December 1984; FDA authorised it on 30 April 1987; FDA authorised it on 13 August 1993.
Who is the marketing authorisation holder for Rocephin in United States?
HOFFMANN LA ROCHE holds the US marketing authorisation.