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Serving leading biopharmaceutical companies globally:

Express Scripts
US Department of Justice
Harvard Business School
Johnson and Johnson

Generated: December 12, 2017

DrugPatentWatch Database Preview

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 nine 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. Twelve suppliers are listed for this compound. Additional details are available on the fenoprofen calcium profile page.

Summary for 017604

Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 017604

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 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:Yes

Expired Orange Book Patents for NDA: 017604

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Xspire PharmaNALFONfenoprofen calciumCAPSULE;ORAL017604-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Xspire PharmaNALFONfenoprofen calciumCAPSULE;ORAL017604-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

US Army

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 verifification 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.

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