Regulatory PathRegulatory requirements compared

Active substance

Nalidixic acid

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ACIDO NALIDIXICO 500 MG TAB500 mgTablet · Oral use56 BlisterSAR 26.85NCE · PrescriptionALMIRALL PRODES PHARMA S.A.Withdrawn by MAH · Not Marketed
ACIDO NALIDIXICO SUSP.125MG-5ML25 mg/mlSyrup · Oral use1 BottleSAR 7.30NCE · PrescriptionALMIRALL PRODES PHARMA S.A.Withdrawn by MAH · Not Marketed
NALIDRAM TAB500 mgTablet · Oral use20 BlisterSAR 10.35Generic · PrescriptionMEMPHIS CHEMICALSWithdrawn by regulatory authority · Not Marketed
NEGRAM 500MG TAB500 mgTablet · Oral use56 BlisterSAR 47.10Generic · PrescriptionSANOFI-SYNTHLABOWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
NEGGRAM250MG; 500MG; 1GMtablet · oralSANOFI AVENTIS USDiscontinued6 Mar 1964
NEGGRAM250MG/5MLsuspension · oralSANOFI AVENTIS USDiscontinued17 Apr 1973
NALIDIXIC ACID250MGtablet · oralSUN PHARM INDUSTRIESDiscontinued28 Mar 1986
NALIDIXIC ACID1GMtablet · oralSUN PHARM INDUSTRIESDiscontinued28 Mar 1986
NALIDIXIC ACID500MGtablet · oralSUN PHARM INDUSTRIESDiscontinued29 Mar 1986
NALIDIXIC ACID1GMtablet · oralWATSON LABSDiscontinued28 Jun 1988
NALIDIXIC ACID250MGtablet · oralWATSON LABSDiscontinued28 Jun 1988
NALIDIXIC ACID500MGtablet · oralWATSON LABSDiscontinued28 Jun 1988

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.