Active substance
Fosphenytoin
- US FDA 16
- Health Canada 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CEREBYX | EQ 50MG PHENYTOIN NA/ML | injectable · injection | PARKE DAVIS | Prescription | 5 Aug 1996 |
| FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | injectable · injection | HIKMA PHARMS | Prescription | 6 Aug 2007 |
| FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | injectable · injection | HIKMA PHARMS | Prescription | 6 Aug 2007 |
| FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | injectable · injection | FRESENIUS KABI USA | Prescription | 6 Aug 2007 |
| FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | injectable · injection | WOCKHARDT BIO AG | Prescription | 6 Aug 2007 |
| FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | injectable · injection | SUN PHARM | Prescription | 18 Mar 2008 |
| FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | injectable · injection | HIKMA FARMACEUTICA | Prescription | 2 Dec 2009 |
| FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | injectable · injection | GLAND | Prescription | 13 Oct 2023 |
| FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | injectable · injection | DR REDDYS | Discontinued | 6 Aug 2007 |
| FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | injectable · injection | APOTEX INC | Discontinued | 6 Aug 2007 |
| FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | injectable · injection | HOSPIRA | Discontinued | 6 Aug 2007 |
| FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | injectable · injection | AM REGENT | Discontinued | 6 Aug 2007 |
| FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | injectable · injection | AMNEAL | Discontinued | 18 Mar 2008 |
| FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | injectable · injection | AM REGENT | Discontinued | 13 May 2010 |
| FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | injectable · injection | PHARMOBEDIENT | Discontinued | 8 Jun 2010 |
| SESQUIENT | EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML); EQ 500MG PHENYTOIN NA/10ML (EQ 50MG PHENYTOIN NA/ML) | solution · intravenous | LUPIN | Discontinued | 5 Nov 2020 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| CEREBYX | 02230988 | 75 MG / ML | SOLUTION · INTRAVENOUS; INTRAMUSCULAR | SEARCHLIGHT PHARMA INC |
Safety signals and safety-related labeling changes
- US FDA 28 Apr 2022 CEREBYX — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; 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.