Regulatory PathRegulatory requirements compared

Active substance

Penicillin g procaine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
PENICILLIN G PROCAINE600,000 UNITS/ML; 300,000 UNITS/MLinjectable · injectionKING PHARMS LLCPrescription26 Apr 1948
PENICILLIN G PROCAINE300,000 UNITS/VIAL; 1,500,000 UNITS/VIALinjectable · injectionPFIZERDiscontinued10 Nov 1948
PFIZERPEN-AS300,000 UNITS/ML; 600,000 UNITS/MLinjectable · injectionPFIZERDiscontinued1 Nov 1950
DURACILLIN A.S.300,000 UNITS/MLinjectable · injectionLILLYDiscontinued
PENICILLIN G PROCAINE300,000 UNITS/ML; 600,000 UNITS/1.2MLinjectable · injectionCONSOLIDATED PHARMDiscontinued
PENICILLIN G PROCAINE300,000 UNITS/MLinjectable · injectionPARKE DAVISDiscontinued

Safety signals and safety-related labeling changes

All safety entries for penicillin g procaine →

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.