Is Flurazepam approved by the US FDA?

Drugs@FDA lists 23 application product lines for Flurazepam, including FLURAZEPAM HYDROCHLORIDE (Prescription); FLURAZEPAM HYDROCHLORIDE (Prescription); FLURAZEPAM HYDROCHLORIDE (Prescription); DALMANE (Discontinued); FLURAZEPAM HYDROCHLORIDE (Discontinued).

Are there safety signals or safety updates for Flurazepam?

EMA PRAC: 1 entry (latest 2026-05-07).

Active substance

Flurazepam

US FDA 23
Health Canada 2
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
FLURAZEPAM HYDROCHLORIDE	30MG; 15MG	capsule · oral	RISING	Prescription	12 Jun 1985
FLURAZEPAM HYDROCHLORIDE	15MG	capsule · oral	CHARTWELL RX	Prescription	30 Mar 1989
FLURAZEPAM HYDROCHLORIDE	30MG	capsule · oral	CHARTWELL RX	Prescription	30 Mar 1989
DALMANE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	VALEANT PHARM INTL	Discontinued	7 Apr 1970
FLURAZEPAM HYDROCHLORIDE	15MG	capsule · oral	NOVITIUM PHARMA	Discontinued	20 Mar 1986
FLURAZEPAM HYDROCHLORIDE	30MG	capsule · oral	NOVITIUM PHARMA	Discontinued	20 Mar 1986
FLURAZEPAM HYDROCHLORIDE	15MG	capsule · oral	SUN PHARM INDUSTRIES	Discontinued	4 Aug 1986
FLURAZEPAM HYDROCHLORIDE	30MG	capsule · oral	SUN PHARM INDUSTRIES	Discontinued	4 Aug 1986
FLURAZEPAM HYDROCHLORIDE	30MG	capsule · oral	CHARTWELL RX	Discontinued	25 Nov 1986
FLURAZEPAM HYDROCHLORIDE	15MG	capsule · oral	CHARTWELL RX	Discontinued	25 Nov 1986
FLURAZEPAM HYDROCHLORIDE	15MG	capsule · oral	HIKMA INTL PHARMS	Discontinued	8 Dec 1986
FLURAZEPAM HYDROCHLORIDE	30MG; 15MG	capsule · oral	HIKMA INTL PHARMS	Discontinued	8 Dec 1986
FLURAZEPAM HYDROCHLORIDE	15MG	capsule · oral	USL PHARMA	Discontinued	9 Jul 1987
FLURAZEPAM HYDROCHLORIDE	30MG	capsule · oral	USL PHARMA	Discontinued	9 Jul 1987
FLURAZEPAM HYDROCHLORIDE	15MG	capsule · oral	HALSEY	Discontinued	7 Jan 1988
FLURAZEPAM HYDROCHLORIDE	30MG	capsule · oral	HALSEY	Discontinued	7 Jan 1988
FLURAZEPAM HYDROCHLORIDE	30MG	capsule · oral	SUPERPHARM	Discontinued	4 Aug 1988
FLURAZEPAM HYDROCHLORIDE	30MG; 15MG	capsule · oral	RISING	Discontinued	31 Jul 1991
FLURAZEPAM HYDROCHLORIDE	30MG	capsule · oral	PUREPAC PHARM	Discontinued
FLURAZEPAM HYDROCHLORIDE	15MG	capsule · oral	SUPERPHARM	Discontinued
FLURAZEPAM HYDROCHLORIDE	15MG	capsule · oral	WARNER CHILCOTT	Discontinued
FLURAZEPAM HYDROCHLORIDE	30MG	capsule · oral	WARNER CHILCOTT	Discontinued
FLURAZEPAM HYDROCHLORIDE	15MG	capsule · oral	PUREPAC PHARM	Discontinued

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
FLURAZEPAM	00521698	15 MG	CAPSULE · ORAL	AA PHARMA INC
FLURAZEPAM	00521701	30 MG	CAPSULE · ORAL	AA PHARMA INC

Safety signals and safety-related labeling changes

EMA PRAC 7 May 2026 PRAC signal: Miscarriage associated with in utero exposure to benzodiazepines (including fixed-dose combinations)
Action for MAH: update of the product information: No

All safety entries for flurazepam →

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.