Regulatory PathRegulatory requirements compared

Active substances

Ampicillin + Sulbactam

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
AMPIPLUS 1.5GM POWDER FOR INGECTION1000,500 mg,mgpowder for solution for injection · Parenteral use50 VialSAR 637.50Generic · PrescriptionANTIBIOTIC S.EValid
Novactam1000,500 mg,mgPowder and solvent for solution for injection · Intramuscular and intravenous use1 VialSAR 12.75Generic · PrescriptionEgyptian International Pharmaceutical Industries Company (EIPICO)Valid
UNASYN 1000:500MG VIAL1000,500 mg,mgpowder for solution for injection · Intramuscular and intravenous use1 VialSAR 12.75NCE · PrescriptionPFIZERValid
UNASYN 500:250MG VIAL250,125 mg,mgpowder for solution for injection · Intramuscular and intravenous use1 VialSAR 9.20NCE · PrescriptionPFIZERValid
Indications — CHI Daman Drug Formulary

ACUTE PANCREATITIS; ACUTE PYELONEPHRITIS; ANTIBIOTIC SURGICAL PROPHYLAXIS; BACTERIAL SKIN INFECTIONS - GAS GANGRENE; BACTERIAL SKIN INFECTIONS - SURGICAL SITE INFECTIONS; COMMUNITY ACQUIRED PNEUMONEA; DENTAL ABSCESS; ENDOCARDITIS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; INTRA-ABDOMINAL INFECTIONS; PELVIC INFLAMMATORY DISEASE; PERITONITIS; RECURRENT URINARY TRACT INFECTIONS (UTI); Septic Shock

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
UNASYNEQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL; EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 10GM BASE/VIAL;EQ 5GM BASE/VIALinjectable · injectionPFIZERPrescription31 Dec 1986
AMPICILLIN AND SULBACTAMEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALinjectable · injectionHIKMA PHARMSPrescription19 Mar 2002
AMPICILLIN AND SULBACTAMEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALinjectable · injectionHQ SPECLT PHARMAPrescription25 Nov 2005
AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIALinjectable · injectionACS DOBFAR SPAPrescription29 Nov 2005
AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIALinjectable · injectionHQ SPECLT PHARMAPrescription30 Nov 2005
AMPICILLIN AND SULBACTAMEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALinjectable · injectionSANDOZPrescription25 Jul 2006
AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIALinjectable · injectionSANDOZPrescription25 Jul 2006
AMPICILLIN AND SULBACTAMEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALinjectable · injectionACS DOBFAR SPAPrescription27 Nov 2006
AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIALinjectable · injectionACS DOBFARPrescription22 Dec 2009
AMPICILLIN AND SULBACTAMEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALinjectable · injectionACS DOBFARPrescription23 Dec 2009
AMPICILLIN AND SULBACTAMEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALinjectable · injectionEUGIA PHARMA SPECLTSPrescription20 Sep 2010
AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIALinjectable · injectionEUGIA PHARMA SPECLTSPrescription20 Sep 2010
AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIALinjectable · injectionONESOURCE SPECIALTYPrescription7 Apr 2014
AMPICILLIN AND SULBACTAMEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALinjectable · injectionONESOURCE SPECIALTYPrescription7 Apr 2014
AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIALinjectable · injectionANTIBIOTICEPrescription7 Dec 2015
UNASYNEQ 500MG BASE/VIAL;EQ 250MG BASE/VIALinjectable · injectionPFIZERDiscontinued31 Dec 1986
UNASYNEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIALinjectable · injectionPFIZERDiscontinued25 Nov 1988
AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIALinjectable · injectionHIKMA PHARMSDiscontinued19 Mar 2002
AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIALinjectable · injectionSANDOZDiscontinued25 Jul 2006
AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIALinjectable · injectionEUROFARMADiscontinued29 Jun 2007
AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIALinjectable · injectionEUGIA PHARMA SPECLTSDiscontinued20 Sep 2010
AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIALinjectable · injectionHOSPIRA INCDiscontinued21 Dec 2011
AMPICILLIN AND SULBACTAMEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALinjectable · injectionHOSPIRA INCDiscontinued21 Dec 2011
AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIALinjectable · injectionHOSPIRA INCDiscontinued21 Dec 2011
AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIALinjectable · injectionASTRALDiscontinued8 Jan 2016

1 more — full table

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.