Details for New Drug Application (NDA): 017604

✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions

NDA 017604 describes NALFON, which is a drug marketed by Xspire Pharma and Dista and is included in two NDAs. It is available from five suppliers. Additional details are available on the NALFON profile page.

The generic ingredient in NALFON is fenoprofen calcium. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fenoprofen calcium profile page.

Summary for 017604

Tradename:	NALFON
Applicant:	Xspire Pharma
Ingredient:	fenoprofen calcium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 017604

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 017604

Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 017604

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NALFON	fenoprofen calcium	CAPSULE;ORAL	017604	NDA	Misemer Pharmaceuticals, Inc.	0276-0501	0276-0501-10	100 CAPSULE in 1 BOTTLE (0276-0501-10)
NALFON	fenoprofen calcium	CAPSULE;ORAL	017604	NDA AUTHORIZED GENERIC	Gentex Pharma	15014-400	15014-400-60	60 CAPSULE in 1 BOTTLE (15014-400-60)

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 300MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 400MG BASE
Approval Date:	Jul 21, 2009	TE:	AB	RLD:	Yes

Expired US Patents for NDA 017604

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Xspire Pharma	NALFON	fenoprofen calcium	CAPSULE;ORAL	017604-002	Approved Prior to Jan 1, 1982	See Plans and Pricing	See Plans and Pricing
Xspire Pharma	NALFON	fenoprofen calcium	CAPSULE;ORAL	017604-003	Approved Prior to Jan 1, 1982	See Plans and Pricing	See Plans and Pricing
>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

Serving leading biopharmaceutical companies globally:

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.