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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 and Dista and is included in two NDAs. It is available from six 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. Eight suppliers are listed for this compound. Additional details are available on the fenoprofen calcium profile page.

Summary for NDA: 017604

Tradename:
NALFON
Applicant:
Xspire
Ingredient:
fenoprofen calcium
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 Xspire Pharma 42195-100 42195-100-90 90 CAPSULE in 1 BOTTLE (42195-100-90)
NALFON
fenoprofen calcium
CAPSULE;ORAL 017604 NDA Xspire Pharma 42195-308 42195-308-09 90 CAPSULE in 1 BOTTLE (42195-308-09)

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 300MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

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

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 400MG BASE
Approval Date:Jul 21, 2009TE:RLD:No

Expired Orange Book Patents for NDA: 017604

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Xspire
NALFON
fenoprofen calcium
CAPSULE;ORAL017604-003Approved Prior to Jan 1, 19823,600,437► subscribe
Xspire
NALFON
fenoprofen calcium
CAPSULE;ORAL017604-002Approved Prior to Jan 1, 19823,600,437► subscribe
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