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Last Updated: July 3, 2020

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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 seven 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. Nine 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 ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 017604
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:DISCNDosage:CAPSULE;ORALStrengthEQ 300MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 400MG BASE
Approval Date:Jul 21, 2009TE:RLD:Yes

Expired US Patents for NDA 017604

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   Start Trial   Start Trial
Xspire Pharma NALFON fenoprofen calcium CAPSULE;ORAL 017604-003 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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