FDA — authorised 29 December 1966
- Application: NDA050072
- Marketing authorisation holder: WYETH AYERST
- Local brand name: PENBRITIN-S
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 AMPICILLIN SODIUM in United States
FDA authorised AMPICILLIN SODIUM on 29 December 1966 · 1,579 US adverse-event reports
Marketing authorisations
FDA — authorised 3 March 1971
- Application: ANDA061395
- Marketing authorisation holder: SANDOZ
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 June 1986
- Application: ANDA062692
- Marketing authorisation holder: HIKMA
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 December 1986
- Application: ANDA062727
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: TOTACILLIN-N
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 February 1987
- Application: ANDA062738
- Marketing authorisation holder: SANDOZ
- Local brand name: AMPICILLIN SODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 12 May 1987
- Application: ANDA062719
- Marketing authorisation holder: ISTITUTO BIO ITA SPA
- Local brand name: AMPICILLIN SODIUM
- 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: ANDA062772
- Marketing authorisation holder: HQ SPECLT PHARMA
- 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 15 April 1993
- Application: ANDA063147
- Marketing authorisation holder: HANFORD GC
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 July 1993
- Application: ANDA062797
- Marketing authorisation holder: ISTITUTO BIO ITA SPA
- 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 19 March 2002
- Application: ANDA065074
- 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 30 November 2005
- Application: ANDA065176
- Marketing authorisation holder: HQ SPECLT PHARMA
- 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 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: ANDA065310
- Marketing authorisation holder: SANDOZ
- Local brand name: AMPICILLIN AND SULBACTAM
- 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 22 December 2009
- Application: ANDA065406
- Marketing authorisation holder: ACS DOBFAR
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 December 2009
- Application: ANDA065403
- Marketing authorisation holder: ACS DOBFAR
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 December 2009
- Application: ANDA090354
- Marketing authorisation holder: ANTIBIOTICE
- Local brand name: AMPICILLIN 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 20 September 2010
- Application: ANDA090349
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 September 2010
- Application: ANDA090340
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 September 2010
- Application: ANDA090339
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 December 2011
- Application: ANDA090646
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 December 2011
- Application: ANDA090375
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: AMPICILLIN AND SULBACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 December 2011
- Application: ANDA090653
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: AMPICILLIN AND SULBACTAM
- 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 3 April 2013
- Application: ANDA090884
- Marketing authorisation holder: ACS DOBFAR SPA
- Local brand name: AMPICILLIN SODIUM
- 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 7 April 2014
- Application: ANDA202197
- 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: ANDA060626
- Marketing authorisation holder: WYETH AYERST
- Local brand name: OMNIPEN-N
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062565
- Marketing authorisation holder: LILLY
- Local brand name: AMPICILLIN SODIUM
- 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: ANDA062718
- Marketing authorisation holder: WYETH AYERST
- Local brand name: OMNIPEN-N
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA060677
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: TOTACILLIN-N
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062860
- Marketing authorisation holder: APOTHECON
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA050309
- Marketing authorisation holder: BRISTOL
- Local brand name: POLYCILLIN-N
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA061936
- Marketing authorisation holder: CONSOLIDATED PHARM
- Local brand name: AMPICILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,579
Most-reported reactions
- Drug Hypersensitivity — 350 reports (22.17%)
- Drug Ineffective — 269 reports (17.04%)
- Pyrexia — 152 reports (9.63%)
- Off Label Use — 144 reports (9.12%)
- Pneumonia — 136 reports (8.61%)
- Rash — 129 reports (8.17%)
- Diarrhoea — 123 reports (7.79%)
- Acute Kidney Injury — 97 reports (6.14%)
- Condition Aggravated — 90 reports (5.7%)
- Dyspnoea — 89 reports (5.64%)
AMPICILLIN SODIUM 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 AMPICILLIN SODIUM approved in United States?
Yes. FDA authorised it on 29 December 1966; FDA authorised it on 3 March 1971; FDA authorised it on 24 June 1986.
Who is the marketing authorisation holder for AMPICILLIN SODIUM in United States?
WYETH AYERST holds the US marketing authorisation.