Details for New Drug Application (NDA): 017821

✉ Email this page to a colleague

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. Fifty-eight 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DISCN	Dosage:	TABLET;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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DISCN	Dosage:	TABLET;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.