Regulatory PathRegulatory requirements compared

Active substance

Zinc sulfate

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML); EQ 25MG BASE/5ML (EQ 5MG BASE/ML); EQ 10MG BASE/10ML (EQ 1MG BASE/ML)solution · intravenousAM REGENTPrescription18 Jul 2019
ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML); EQ 30MG BASE/10ML (EQ 3MG BASE/ML); EQ 10MG BASE/10ML (EQ 1MG BASE/ML)solution · intravenousGLANDPrescription3 May 2022
ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML); EQ 25MG BASE/5ML (EQ 5MG BASE/ML); EQ 30MG BASE/10ML (EQ 3MG BASE/ML)solution · intravenousFRESENIUS KABI USAPrescription27 Dec 2022
ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML); EQ 25MG BASE/5ML (EQ 5MG BASE/ML); EQ 30MG BASE/10ML (EQ 3MG BASE/ML)solution · intravenousZYDUS PHARMSPrescription22 Aug 2023
ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML); EQ 10MG BASE/10ML (EQ 1MG BASE/ML)solution · intravenousAPOTEXPrescription10 Jun 2024
ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML); EQ 25MG BASE/5ML (EQ 5MG BASE/ML); EQ 30MG BASE/10ML (EQ 3MG BASE/ML)solution · intravenousNIVAGENPrescription5 Jul 2024
ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML); EQ 30MG BASE/10ML (EQ 3MG BASE/ML)solution · intravenousSOMERSET THERAPS LLCPrescription17 Jul 2024
ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML); EQ 25MG BASE/5ML (EQ 5MG BASE/ML); EQ 30MG BASE/10ML (EQ 3MG BASE/ML)solution · intravenousASPIROPrescription1 May 2025
ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML); EQ 25MG BASE/5ML (EQ 5MG BASE/ML); EQ 30MG BASE/10ML (EQ 3MG BASE/ML)solution · intravenousSTIRAPrescription10 Jun 2025
ZINC SULFATEEQ 1MG ZINC/MLinjectable · injectionABRAXIS PHARMDiscontinued5 May 1987

WHO WHO Model List of Essential Medicines (2025)

  • 17.5.2. Medicines for diarrhoea · core
    Diarrhoea
    Oral > Solid > dispersible tablet: 20 mg (scored)

Safety signals and safety-related labeling changes

All safety entries for zinc sulfate →

Combinations containing Zinc sulfate

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.