FDA — authorised 29 December 1966
- Application: NDA050072
- Marketing authorisation holder: WYETH AYERST
- Local brand name: PENBRITIN-S
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Ampicillin + gentamicin or cefotaxime + gentamicin in United States
FDA authorised Ampicillin + gentamicin or cefotaxime + gentamicin on 29 December 1966
Marketing authorisations
FDA — authorised 20 May 1985
- Application: NDA050596
- Marketing authorisation holder: STERIMAX
- Local brand name: CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 September 1988
- Application: ANDA062994
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 April 1993
- Application: ANDA063147
- Marketing authorisation holder: HANFORD GC
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 April 1993
- Application: ANDA063142
- Marketing authorisation holder: HQ SPECLT PHARMA
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 March 2002
- Application: ANDA065074
- Marketing authorisation holder: HIKMA
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 March 2002
- Application: ANDA065076
- Marketing authorisation holder: HIKMA
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 November 2005
- Application: ANDA065222
- Marketing authorisation holder: ISTITUTO BIO ITA SPA
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 July 2006
- Application: ANDA065310
- Marketing authorisation holder: SANDOZ
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 July 2006
- Application: ANDA065240
- Marketing authorisation holder: SANDOZ
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 July 2006
- Application: ANDA065241
- Marketing authorisation holder: SANDOZ
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 August 2006
- Application: ANDA065293
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: CEFOTAXIME SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 August 2006
- Application: ANDA065292
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: CEFOTAXIME SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 August 2006
- Application: ANDA065290
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: CEFOTAXIME SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 November 2006
- Application: ANDA065314
- Marketing authorisation holder: ISTITUTO BIO ITA SPA
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 June 2007
- Application: ANDA065316
- Marketing authorisation holder: EUROFARMA
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 November 2009
- Application: ANDA065516
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CEFOTAXIME SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 November 2009
- Application: ANDA065517
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CEFOTAXIME SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 January 2010
- Application: ANDA065348
- Marketing authorisation holder: CEPHAZONE PHARMA
- Local brand name: CEFOTAXIME SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 August 2010
- Application: ANDA065499
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 April 2013
- Application: ANDA090884
- Marketing authorisation holder: ACS DOBFAR SPA
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 April 2013
- Application: ANDA090889
- Marketing authorisation holder: ACS DOBFAR SPA
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 April 2014
- Application: ANDA202197
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 April 2014
- Application: ANDA202198
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 April 2014
- Application: ANDA201024
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 April 2014
- Application: ANDA201025
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 September 2015
- Application: ANDA202865
- Marketing authorisation holder: HOSPIRA
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 September 2015
- Application: ANDA202864
- Marketing authorisation holder: HOSPIRA
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 October 2015
- Application: ANDA090581
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 November 2015
- Application: ANDA090583
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 January 2016
- Application: ANDA090579
- Marketing authorisation holder: ASTRAL
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 January 2016
- Application: ANDA090578
- Marketing authorisation holder: ASTRAL
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA060677
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: TOTACILLIN-N
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062634
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062860
- Marketing authorisation holder: APOTHECON
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA061936
- Marketing authorisation holder: CONSOLIDATED PHARM
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062565
- Marketing authorisation holder: LILLY
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA060626
- Marketing authorisation holder: WYETH AYERST
- Local brand name: OMNIPEN-N
- Indication: INJECTABLE — INJECTION
- Status: approved
Other Infectious Disease approved in United States
Frequently asked questions
Is Ampicillin + gentamicin or cefotaxime + gentamicin approved in United States?
Yes. FDA authorised it on 29 December 1966; FDA authorised it on 20 May 1985; FDA authorised it on 15 September 1988.
Who is the marketing authorisation holder for Ampicillin + gentamicin or cefotaxime + gentamicin in United States?
WYETH AYERST holds the US marketing authorisation.