Last Updated: August 2, 2026

Details for New Drug Application (NDA): 017821

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NDA 017821 describes FLEXERIL, which is a drug marketed by Janssen Res And Dev and is included in one NDA. Additional details are available on the FLEXERIL profile page.

The generic ingredient in FLEXERIL is cyclobenzaprine hydrochloride. There are sixteen drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.

Summary for 017821

Tradename:	FLEXERIL
Applicant:	Janssen Res And Dev
Ingredient:	cyclobenzaprine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 017821

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-001	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-002	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-002	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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