Is Cyclobenzaprine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Cyclobenzaprine, including BENZAFLEX 10 mg Film-Coated Tablets (10 mg, Film-coated tablet, SAR 23.05); BENZAFLEX 5 mg Film-Coated Tablets (5 mg, Film-coated tablet, SAR 11.50); BENZAFLEX XR 15 mg Capsule (15 mg, Capsule, hard, SAR 31.10); BENZAFLEX XR 30 mg Capsule (30 mg, Capsule, hard, SAR 62.20); PROLAX ER 15 mg extended-release capsule (15 mg, Extended-release capsule, SAR 34.55).

Is Cyclobenzaprine approved by the US FDA?

Drugs@FDA lists 26 application product lines for Cyclobenzaprine, including CYCLOBENZAPRINE HYDROCHLORIDE (Prescription); CYCLOBENZAPRINE HYDROCHLORIDE (Prescription); CYCLOBENZAPRINE HYDROCHLORIDE (Prescription); CYCLOBENZAPRINE HYDROCHLORIDE (Prescription); CYCLOBENZAPRINE HYDROCHLORIDE (Prescription).

Are there safety signals or safety updates for Cyclobenzaprine?

US FDA: 1 entry (latest 2019-04-23).

Active substance

Cyclobenzaprine

SFDA 10
US FDA 26
Health Canada 10
US price lines 8
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BENZAFLEX 10 mg Film-Coated Tablets	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 23.05	Generic · Prescription	SPIMACO ADDWAEIH	Valid
BENZAFLEX 5 mg Film-Coated Tablets	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 11.50	Generic · Prescription	SPIMACO ADDWAEIH	Valid
BENZAFLEX XR 15 mg Capsule	15 mg	Capsule, hard · Oral use	30 Blister	SAR 31.10	Generic · Prescription	SPIMACO ADDWAEIH	Valid
BENZAFLEX XR 30 mg Capsule	30 mg	Capsule, hard · Oral use	30 Blister	SAR 62.20	Generic · Prescription	SPIMACO ADDWAEIH	Valid
PROLAX ER 15 mg extended-release capsule	15 mg	Extended-release capsule · Oral use	30 Bottle	SAR 34.55	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
PROLAX ER 30 mg extended-release capsule	30 mg	Extended-release capsule · Oral use	30 Bottle	SAR 69.10	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
MYOLAX 15MG EXTENDED RELEASE CAPSULE	15 mg	Prolonged-release capsule, hard · Oral use	30 Bottle	SAR 38.40	Generic · Prescription	PFIZER SAUDI LIMITED	Withdrawn by MAH · Not Marketed
MYOLAX 30MG EXTENDED RELEASE CAPSULE	30 mg	Prolonged-release capsule, hard · Oral use	30 Bottle	SAR 76.80	Generic · Prescription	PFIZER SAUDI LIMITED	Withdrawn by MAH · Not Marketed
PROLAX 15MG EXTENDED RELEASE CAPSULE	15 mg	Extended-release capsule · Oral use	30 Bottle	SAR 38.40	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
PROLAX 30MG EXTENDED RELEASE CAPSULE	30 mg	Extended-release capsule · Oral use	30 Bottle	SAR 76.80	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

FIBROMYALGIA; LOW BACK PAIN

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

Product	Strength	Form · route	Applicant	Status	First approved
CYCLOBENZAPRINE HYDROCHLORIDE	10MG; 5MG; 7.5MG	tablet · oral	ACTAVIS LABS FL INC	Prescription	29 Feb 1988
CYCLOBENZAPRINE HYDROCHLORIDE	10MG; 5MG; 7.5MG	tablet · oral	AIPING PHARM INC	Prescription	19 Nov 1991
CYCLOBENZAPRINE HYDROCHLORIDE	10MG; 5MG	tablet · oral	TP ANDA HOLDINGS	Prescription	23 May 1995
CYCLOBENZAPRINE HYDROCHLORIDE	10MG; 5MG	tablet · oral	TP ANDA HOLDINGS	Prescription	4 Oct 2005
CYCLOBENZAPRINE HYDROCHLORIDE	5MG; 10MG; 7.5MG	tablet · oral	JUBILANT CADISTA	Prescription	19 Apr 2006
AMRIX	15MG; 30MG	capsule, extended release · oral	TEVA PHARMS INTL	Prescription	1 Feb 2007
CYCLOBENZAPRINE HYDROCHLORIDE	5MG; 10MG	tablet · oral	PRINSTON INC	Prescription	28 Feb 2007
CYCLOBENZAPRINE HYDROCHLORIDE	10MG; 5MG; 7.5MG	tablet · oral	CHARTWELL RX	Prescription	18 Apr 2008
CYCLOBENZAPRINE HYDROCHLORIDE	5MG; 10MG	tablet · oral	AUROBINDO PHARMA	Prescription	26 Sep 2008
CYCLOBENZAPRINE HYDROCHLORIDE	5MG; 10MG	tablet · oral	INVAGEN PHARMS	Prescription	23 Jul 2010
CYCLOBENZAPRINE HYDROCHLORIDE	5MG; 10MG	tablet · oral	KVK TECH	Prescription	28 Feb 2011
CYCLOBENZAPRINE HYDROCHLORIDE	15MG; 30MG	capsule, extended release · oral	TWI PHARMS INC	Prescription	31 Jan 2013
CYCLOBENZAPRINE HYDROCHLORIDE	5MG; 7.5MG; 10MG	tablet · oral	RUBICON RESEARCH	Prescription	31 May 2017
CYCLOBENZAPRINE HYDROCHLORIDE	5MG; 7.5MG; 10MG	tablet · oral	UNICHEM	Prescription	6 Jul 2020
CYCLOBENZAPRINE HYDROCHLORIDE	15MG; 30MG	capsule, extended release · oral	MACLEODS PHARMS	Prescription	22 Jul 2024
CYCLOBENZAPRINE HYDROCHLORIDE	15MG; 30MG	capsule, extended release · oral	NOVAST LABS	Prescription	27 Aug 2024
CYCLOBENZAPRINE HYDROCHLORIDE	5MG; 7.5MG; 10MG	tablet · oral	RISING	Prescription	12 Sep 2024
TONMYA	2.8MG	tablet · sublingual	TONIX	Prescription	15 Aug 2025
FLEXERIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	JANSSEN RES AND DEV	Discontinued	26 Aug 1977
CYCLOBENZAPRINE HYDROCHLORIDE	10MG; 5MG; 7.5MG	tablet · oral	RISING	Discontinued	31 May 1991
CYCLOBENZAPRINE HYDROCHLORIDE	10MG	tablet · oral	WATSON LABS	Discontinued	27 Nov 1991
CYCLOBENZAPRINE HYDROCHLORIDE	10MG	tablet · oral	SANDOZ	Discontinued	26 Feb 1993
CYCLOBENZAPRINE HYDROCHLORIDE	10MG	tablet · oral	WATSON LABS	Discontinued	30 Nov 1994
CYCLOBENZAPRINE HYDROCHLORIDE	10MG	tablet · oral	PLIVA	Discontinued	29 Sep 1995
CYCLOBENZAPRINE HYDROCHLORIDE	5MG; 7.5MG; 10MG	tablet · oral	SUN PHARM INDS LTD	Discontinued	12 May 2008

1 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AG-CYCLOBENZAPRINE	02485419	10 MG	TABLET · ORAL	ANGITA PHARMA INC.
APO-CYCLOBENZAPRINE	02177145	10 MG	TABLET · ORAL	APOTEX INC
AURO-CYCLOBENZAPRINE	02348853	10 MG	TABLET · ORAL	AURO PHARMA INC
CYCLOBENZAPRINE	02287064	10 MG	TABLET · ORAL	SANIS HEALTH INC
CYCLOBENZAPRINE	02424584	10 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
JAMP-CYCLOBENZAPRINE	02357127	10 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
PMS-CYCLOBENZAPRINE - TAB 10MG	02212048	10 MG	TABLET · ORAL	PHARMASCIENCE INC
PRO-CYCLOBENZAPRINE	02220644	10 MG	TABLET · ORAL	PRO DOC LIMITEE
RIVA-CYCLOBENZAPRINE	02242079	10 MG	TABLET · ORAL	LABORATOIRE RIVA INC.
TEVA-CYCLOBENZAPRINE	02080052	10 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AMRIX ER 15 MG CAPSULE	$66.23256	per EA	1 Jan 2026
US NADAC	AMRIX ER 30 MG CAPSULE	$66.56709	per EA	1 Jan 2026
US NADAC	CYCLOBENZAPRINE 10 MG TABLET	$0.01712	per EA	23 Sep 2026
US NADAC	CYCLOBENZAPRINE 5 MG TABLET	$0.02197	per EA	23 Sep 2026
US NADAC	CYCLOBENZAPRINE 7.5 MG TABLET	$0.26288	per EA	23 Sep 2026
US NADAC	CYCLOBENZAPRINE ER 15 MG CAP	$1.18556	per EA	23 Sep 2026
US NADAC	CYCLOBENZAPRINE ER 30 MG CAP	$1.0822	per EA	23 Sep 2026
US NADAC	TONMYA 2.8 MG TABLET SL	$29.60952	per EA	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 23 Apr 2019 AMRIX — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations

All safety entries for cyclobenzaprine →

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.