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Last Updated: April 20, 2024

Details for New Drug Application (NDA): 017604

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NDA 017604 describes NALFON, which is a drug marketed by Xspire Pharma and Dista and is included in two NDAs. It is available from four 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 AUTHORIZED GENERIC	Gentex Pharma	15014-400	15014-400-60	60 CAPSULE in 1 BOTTLE (15014-400-60)
NALFON	fenoprofen calcium	CAPSULE;ORAL	017604	NDA AUTHORIZED GENERIC	Gentex Pharma	15014-400	15014-400-90	90 CAPSULE in 1 BOTTLE (15014-400-90)

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:	AB	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

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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	⤷ Try a Trial	⤷ Try a Trial
Xspire Pharma	NALFON	fenoprofen calcium	CAPSULE;ORAL	017604-003	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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