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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 017604


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NDA 017604 describes NALFON, which is a drug marketed by Key Therap 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:Key Therap
Ingredient:fenoprofen calcium
Patents:0
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300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

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

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage: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
Key Therap NALFON fenoprofen calcium CAPSULE;ORAL 017604-002 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Key Therap NALFON fenoprofen calcium CAPSULE;ORAL 017604-003 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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