Regulatory PathRegulatory requirements compared

Active substances

Amoxicillin + Clavulanic acid

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
AMOCLAN200,1000 mg,mgPowder for injection · Parenteral use10 VialSAR 88.25Generic · PrescriptionHikma Pharmaceuticals PLCValid
AMOCLAN 1.2 GM VIAL1000,200 mg,mgPowder for solution for injection/infusion · Parenteral use1 VialSAR 14.60Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
AMOXIPLUS 1.2GM Powder for injection1000,200 mg,mgpowder for solution for injection · Parenteral use50 VialSAR 333.00Generic · PrescriptionANTIBIOTIC S.EValid
AUGMENTIN 1 G TAB875,125 mg,mgTablet · Oral use14 BlisterSAR 78.30NCE · PrescriptionGLAXO SAUDI ARABIAValid
AUGMENTIN 156 Mg-5 ML SUSPENSION125,31.25 mg,mgPowder for oral suspension · Oral use1 BottleSAR 17.35NCE · PrescriptionGLAXO SAUDI ARABIAValid
AUGMENTIN 228 MG-5ML SUSPENSION200,28.5 mg,mgSuspension · Oral use1 BottleSAR 19.20NCE · PrescriptionGLAXO SAUDI ARABIAValid
AUGMENTIN 312 MG-5ML SUSPENSION50,12.5 mg/ml,mg/mlPowder for oral suspension · Oral use1 BottleSAR 32.55NCE · PrescriptionGLAXO SAUDI ARABIAValid
AUGMENTIN 457MG-5ML SUSPENSION400,57 mg,mgSuspension · Oral use1 BottleSAR 33.05NCE · PrescriptionGLAXO SAUDI ARABIAValid
AUGMENTIN 625 MG TAB500,125 mg,mgTablet · Oral use20 BlisterSAR 63.80NCE · PrescriptionGLAXO SAUDI ARABIAValid
AUGMENTIN ES SUSPENSION600,42.9 mg,mgPowder for oral suspension · Oral use1 BottleSAR 32.65NCE · PrescriptionGLAXO SAUDI ARABIAValid
AUGMENTIN INFANT DROP50,12.5 mg,mgPowder for oral suspension · Oral use1 BottleSAR 19.10NCE · PrescriptionGLAXO SAUDI ARABIAValid
AUGMENTIN TAB 375 MG250,125 mg,mgTablet · Oral use20 BlisterSAR 36.75NCE · PrescriptionGLAXO SAUDI ARABIAValid
CLAVODAR 1GM F.C. TABLETS875,125 mg,mgTablet · Oral use14 BlisterSAR 44.60Generic · PrescriptionDAR ALDAWAValid
CLAVODAR 457MG/5ML SUSPENSION80,11.4 mg/ml,mg/mlSuspension · Oral use1 BottleSAR 16.50Generic · PrescriptionDAR ALDAWAValid
CLAVODAR 625GM FILM COATED TABLET500,125 mg,mgFilm-coated tablet · Oral use20 BlisterSAR 24.80Generic · PrescriptionDAR ALDAWAValid
CURAM 1.2GM POW. FOR SOLN. FOR INJECTION- INFUSION1000,200 mg,mgPowder for solution for injection/infusion · Parenteral use10 VialSAR 94.85Generic · PrescriptionSANDOZValid
CURAM 156.25MG-5ML POWDER FOR SUSP125,31.25 mg,mgPowder for oral suspension · Oral use1 BottleSAR 10.35Generic · PrescriptionSANDOZValid
CURAM 1GM TABLET875,125 mg,mgFilm-coated tablet · Oral use14 BlisterSAR 44.15Generic · PrescriptionSANDOZValid
CURAM 312.5 MG-5ML POWDER FOR SUSP250,62.5 mg,mgPowder for oral suspension · Oral use100 BottleSAR 18.10Generic · PrescriptionSANDOZValid
CURAM 457MG-5ML POW. FOR ORAL SUSPENSION400,57 mg/ml,mg/mlPowder for oral suspension · Oral use70 BottleSAR 18.35Generic · PrescriptionSANDOZValid
CURAM 600MG POW. FOR SOLN. FOR INJECTION- INFUSION500,100 mg,mgPowder for solution for injection/infusion · Parenteral use10 VialSAR 46.90Generic · PrescriptionSANDOZValid
CURAM 625 MG F.C TAB500,125 mg,mgFilm-coated tablet · Oral use20 BlisterSAR 21.85Generic · PrescriptionSANDOZValid
Clavodar ES Suspension600,62.9 mg,mgPowder for oral suspension · Oral use1 BottleSAR 29.40Generic · PrescriptionDAR ALDAWAValid
GLOCLAV 1GM FILM COATED TABLETS875,125 mg,mgFilm-coated tablet · Oral use14 BlisterSAR 56.80Generic · PrescriptionGLOBAL PHARMAValid
GLOCLAV 375MG TAB250,125 mg,mgFilm-coated tablet · Oral use20 BlisterSAR 27.70Generic · PrescriptionGLOBAL PHARMAValid

79 more — full table

Indications — CHI Daman Drug Formulary

ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS); ACUTE PYELONEPHRITIS; BACTERIAL SKIN INFECTIONS - ERYSIPELAS AND CELLULITIS; BACTERIAL SKIN INFECTIONS - GAS GANGRENE; BACTERIAL SKIN INFECTIONS - IMPETIGO AND ECTHYMA; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; COMMUNITY ACQUIRED PNEUMONEA; DENTAL ABSCESS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; OSTEOMYELITIS; OTITIS MEDIA; PHARYNGITIS; Pyogenic Arthritis; RECURRENT URINARY TRACT INFECTIONS (UTI); Septic Shock; SINUSITIS; TUBERCULOSIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
AUGMENTIN '125'125MG/5ML;EQ 31.25MG BASE/5MLfor suspension · oralUS ANTIBIOTICSPrescription6 Aug 1984
AUGMENTIN '250'250MG/5ML;EQ 62.5MG BASE/5MLfor suspension · oralUS ANTIBIOTICSPrescription6 Aug 1984
AUGMENTIN '875'875MG;EQ 125MG BASEtablet · oralUS ANTIBIOTICSPrescription13 Feb 1996
AUGMENTIN ES-600600MG/5ML;EQ 42.9MG BASE/5MLfor suspension · oralUS ANTIBIOTICSPrescription22 Jun 2001
AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASEtablet · oralSANDOZPrescription14 Mar 2002
AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASEtablet · oralSANDOZPrescription15 Mar 2002
AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5ML; 400MG/5ML;EQ 57MG BASE/5MLfor suspension · oralSANDOZPrescription5 Jun 2002
AUGMENTIN XR1GM;EQ 62.5MG BASEtablet, extended release · oralUS ANTIBIOTICSPrescription25 Sep 2002
AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASEtablet · oralCHARTWELL RXPrescription29 Oct 2002
AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASEtablet · oralCHARTWELL RXPrescription30 Oct 2002
AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASEtablet · oralSANDOZ INCPrescription21 Nov 2002
AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5ML; 400MG/5ML;EQ 57MG BASE/5MLfor suspension · oralSANDOZ INCPrescription16 Dec 2002
AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLfor suspension · oralCHARTWELL RXPrescription12 Mar 2004
AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5ML; 400MG/5ML;EQ 57MG BASE/5MLfor suspension · oralCHARTWELL RXPrescription25 May 2004
AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5ML; 200MG/5ML;EQ 28.5MG BASE/5MLfor suspension · oralHIKMA PHARMSPrescription25 Jan 2005
AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASE; 400MG;EQ 57MG BASEtablet, chewable · oralCHARTWELL RXPrescription9 Feb 2005
AMOXICILLIN AND CLAVULANATE POTASSIUM250MG;EQ 125MG BASEtablet · oralSANDOZPrescription23 Aug 2005
AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLfor suspension · oralSANDOZ INCPrescription13 Aug 2007
AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLfor suspension · oralHIKMA PHARMSPrescription9 Nov 2007
AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLfor suspension · oralCIPLAPrescription25 Nov 2008
AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASEtablet, extended release · oralSANDOZPrescription21 Apr 2010
AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5ML; 400MG/5ML;EQ 57MG BASE/5MLfor suspension · oralAUROBINDO PHARMA LTDPrescription20 Dec 2011
AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLfor suspension · oralAUROBINDO PHARMA LTDPrescription20 Dec 2011
AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASEtablet · oralAUROBINDO PHARMA LTDPrescription20 Jan 2012
AMOXICILLIN AND CLAVULANATE POTASSIUM250MG;EQ 125MG BASE; 500MG;EQ 125MG BASEtablet · oralAUROBINDO PHARMA LTDPrescription20 Jan 2012

29 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AG-AMOXI CLAV02510634125 MG; 500 MGTABLET · ORALANGITA PHARMA INC.
AG-AMOXI CLAV02510642875 MG; 125 MGTABLET · ORALANGITA PHARMA INC.
AMOXICILLIN SODIUM AND POTASSIUM CLAVULANATE FOR INJECTION02495910500 MG / VIAL; 100 MG / VIALPOWDER FOR SOLUTION · INTRAVENOUSSANDOZ CANADA INCORPORATED
AMOXICILLIN SODIUM AND POTASSIUM CLAVULANATE FOR INJECTION02495929200 MG / VIAL; 1000 MG / VIALPOWDER FOR SOLUTION · INTRAVENOUSSANDOZ CANADA INCORPORATED
AMOXICILLIN SODIUM AND POTASSIUM CLAVULANATE FOR INJECTION024959372000 MG / VIAL; 200 MG / VIALPOWDER FOR SOLUTION · INTRAVENOUSSANDOZ CANADA INCORPORATED
AMOXICILLIN/CLAV02536021500 MG; 125 MGTABLET · ORALSANIS HEALTH INC
AMOXICILLIN/CLAV02536048125 MG; 875 MGTABLET · ORALSANIS HEALTH INC
APO-AMOXI CLAV02243350125 MG; 250 MGTABLET · ORALAPOTEX INC
APO-AMOXI CLAV02243351500 MG; 125 MGTABLET · ORALAPOTEX INC
APO-AMOXI CLAV02245623875 MG; 125 MGTABLET · ORALAPOTEX INC
AURO-AMOXICLAV02471671250 MG; 125 MGTABLET · ORALAURO PHARMA INC
AURO-AMOXICLAV02471698500 MG; 125 MGTABLET · ORALAURO PHARMA INC
AURO-AMOXICLAV02471701875 MG; 125 MGTABLET · ORALAURO PHARMA INC
CLAVULIN 125 F ORAL SUS0191688231.25 MG / 5 ML; 125 MG / 5 MLPOWDER FOR SUSPENSION · ORALGLAXOSMITHKLINE INC
CLAVULIN 20002238831200 MG / 5 ML; 28.5 MG / 5 MLPOWDER FOR SUSPENSION · ORALGLAXOSMITHKLINE INC
CLAVULIN 250 F ORAL SUS0191687462.5 MG / 5 ML; 250 MG / 5 MLPOWDER FOR SUSPENSION · ORALGLAXOSMITHKLINE INC
CLAVULIN 4000223883057 MG / 5 ML; 400 MG / 5 MLPOWDER FOR SUSPENSION · ORALGLAXOSMITHKLINE INC
JAMP AMOXI CLAV02508249125 MG; 250 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP AMOXI CLAV02508257500 MG; 125 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP AMOXI CLAV02508265875 MG; 125 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP AMOXI CLAV SUSPENSION02539438250 MG / 5 ML; 62.5 MG / 5 MLPOWDER FOR SUSPENSION · ORALJAMP PHARMA CORPORATION
JAMP AMOXI CLAV SUSPENSION02539446400 MG / 5 ML; 57 MG / 5 MLPOWDER FOR SUSPENSION · ORALJAMP PHARMA CORPORATION
M-AMOXI CLAV02530694400 MG / 5 ML; 57 MG / 5 MLPOWDER FOR SUSPENSION · ORALMANTRA PHARMA INC
M-AMOXI CLAV02542226250 MG / 5 ML; 62.5 MG / 5 MLPOWDER FOR SUSPENSION · ORALMANTRA PHARMA INC
PRO-AMOXI CLAV02536498500 MG; 125 MGTABLET · ORALPRO DOC LIMITEE

3 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACAMOX-CLAV 200-28.5 MG/5 ML SUS$0.04807per ML23 Sep 2026
US NADACAMOX-CLAV 200-28.5 MG/5 ML SUS$0.06998per ML23 Sep 2026
US NADACAMOX-CLAV 200-28.5 MG/5 ML SUS$0.05928per ML23 Sep 2026
US NADACAMOX-CLAV 250-125 MG TABLET$1.53115per EA23 Sep 2026
US NADACAMOX-CLAV 250-62.5 MG/5 ML SUS$0.45512per ML23 Sep 2026
US NADACAMOX-CLAV 250-62.5 MG/5 ML SUS$0.39204per ML23 Sep 2026
US NADACAMOX-CLAV 250-62.5 MG/5 ML SUS$0.43537per ML23 Sep 2026
US NADACAMOX-CLAV 400-57 MG/5 ML SUSP$0.05616per ML23 Sep 2026
US NADACAMOX-CLAV 400-57 MG/5 ML SUSP$0.08432per ML23 Sep 2026
US NADACAMOX-CLAV 400-57 MG/5 ML SUSP$0.06578per ML23 Sep 2026
US NADACAMOX-CLAV 500-125 MG TABLET$0.25341per EA23 Sep 2026
US NADACAMOX-CLAV 600-42.9 MG/5 ML SUS$0.0693per ML23 Sep 2026
NHS Drug TariffCo-amoxiclav 125mg/31mg/5ml oral suspension£3.54100 ml1 Oct 2026
NHS Drug TariffCo-amoxiclav 250mg/125mg tablets£1.6721 tablet1 Oct 2026
NHS Drug TariffCo-amoxiclav 250mg/62mg/5ml oral suspension£3.60100 ml1 Oct 2026
NHS Drug TariffCo-amoxiclav 250mg/62mg/5ml oral suspension sugar free£6.25100 ml1 Oct 2026
NHS Drug TariffCo-amoxiclav 400mg/57mg/5ml oral suspension£4.1335 ml1 Oct 2026
NHS Drug TariffCo-amoxiclav 400mg/57mg/5ml oral suspension£5.7970 ml1 Oct 2026
NHS Drug TariffCo-amoxiclav 400mg/57mg/5ml oral suspension sugar free£3.4970 ml1 Oct 2026
NHS Drug TariffCo-amoxiclav 500mg/125mg tablets£1.9821 tablet1 Oct 2026
NHS Drug TariffCo-amoxiclav 875mg/125mg tablets£5.9914 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 6.2.1. Access group antibiotics · core
    First choice: Bacterial pneumonia (Community-acquired pneumonia - severe) [children]; First choice: Acute sinusitis; First choice: Other specified pneumonia (Hospital-acquired pneumonia); First choice: Chronic obstructive pulmonary disease with acute exacerbation; First choice: Neutropaenia (low-risk); First choice: Peritoneal abscess (mild-moderate); First choice: Peritonitis (mild-moderate); First choice: Infectious cystitis; First choice: Bacterial cellulitis, erysipelas or lymphangitis; Second choice: Bacterial pneumonia (Community-acquired pneumonia - mild to moderate); Second choice: Bacterial pneumonia (Community-acquired pneumonia - severe); Second choice: Bacterial infection of joint; Second choice: Acute otitis media; Second choice: Other specified prophylactic measures; Second choice: Osteomyelitis or osteitis
    Parenteral > General injections > IV: 500 mg (as sodium salt) + 100 mg (as potassium salt) powder for injection; 1000 mg (as sodium salt) + 200 mg (as potassium salt) powder for injection | Oral > Liquid: 125 mg (as trihydrate) + 31.25 mg (as potassium salt) / 5 mL powder for oral liquid (EMLc); 250 mg (as trihydrate) + 62.5 mg (as potassium salt) / 5 mL powder for oral liquid (EMLc) | Oral > Solid > dispersible tablet: 200 mg (as trihydrate) + 28.5 mg (as potassium salt) (EMLc); 250 mg (as trihydrate) + 62.5 mg (as potassium salt) (EMLc) | Oral > Solid > tablet: 500 mg (as trihydrate) + 125 mg (as potassium salt); 875 mg (as trihydrate) + 125 mg (as potassium salt) (EML) | Oral > Solid > tablet: 500 mg (as trihydrate) + 125 mg (as potassium salt)
  • 6.2.5. Antituberculosis medicines · core
    Multi-drug resistant Mycobacterium tuberculosis
    Oral > Liquid: 250 mg (as trihydrate) + 62.5 mg (as potassium salt) / 5 mL powder for oral liquid (EMLc) | Oral > Solid > dispersible tablet: 250 (as trihydrate) + 62.5 (as potassium salt) (EMLc) | Oral > Solid > tablet: 500 mg (as trihydrate) + 125 mg (as potassium salt)

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.