Regulatory PathRegulatory requirements compared

Active substance

Dipivefrin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
OFTANEX 0.1% EYE DROPS0.1 %Eye drops · Topical1 Dropper ContainerSAR 28.55NCE · PrescriptionBAYER SCHERING PHARMAWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
PROPINE0.1%solution/drops · ophthalmicALLERGANDiscontinued2 May 1980
DIPIVEFRIN HYDROCHLORIDE0.1%solution/drops · ophthalmicFALCON PHARMSDiscontinued30 Jun 1994
DIPIVEFRIN HYDROCHLORIDE0.1%solution/drops · ophthalmicBAUSCH AND LOMBDiscontinued19 May 1995
AKPRO0.1%solution/drops · ophthalmicEPIC PHARMA LLCDiscontinued29 Sep 1995

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.