Active substance
Pralidoxime
- SFDA 2
- US FDA 5
- Safety 2
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| OXIDOTE 1GM VIAL | 1 g | powder for solution for injection · Intramuscular and intravenous use | 6 Vial | SAR 1694.75 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| Pretava | 1 g | Powder for solution for injection/infusion · Intravenous use | 6 Vial | SAR 1581.75 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PROTOPAM CHLORIDE | 1GM/VIAL | injectable · injection | BAXTER HLTHCARE CORP | Prescription | 11 Mar 1964 |
| PROTOPAM CHLORIDE | 500MG | tablet · oral | WYETH AYERST | Discontinued | 12 Mar 1964 |
| PROTOPAM CHLORIDE | 300MG/ML | injectable · injection | BAXTER HLTHCARE CORP | Discontinued | 13 Dec 1982 |
| PRALIDOXIME CHLORIDE (AUTOINJECTOR) | 600MG/2ML (300MG/ML) | solution · intramuscular | MERIDIAN MEDCL TECHN | Discontinued | 26 Apr 1983 |
| PRALIDOXIME CHLORIDE | 1GM/VIAL | injectable · injection | QUAD PHARMS | Discontinued |
Safety signals and safety-related labeling changes
- US FDA 22 May 2020 ATNAA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 6 Oct 2017 DUODOTE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.