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Generated: July 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020584

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NDA 020584 describes LODINE XL, which is a drug marketed by Wyeth Pharms Inc and is included in one NDA. Additional details are available on the LODINE XL profile page.

The generic ingredient in LODINE XL is etodolac. There are twenty-two drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the etodolac profile page.

Summary for NDA: 020584

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 25, 1996TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 25, 1996TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jan 20, 1998TE:RLD:No

Expired Orange Book Patents for NDA: 020584

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms Inc
LODINE XL
etodolac
TABLET, EXTENDED RELEASE;ORAL020584-001Oct 25, 1996► Subscribe► Subscribe
Wyeth Pharms Inc
LODINE XL
etodolac
TABLET, EXTENDED RELEASE;ORAL020584-003Jan 20, 1998► Subscribe► Subscribe
Wyeth Pharms Inc
LODINE XL
etodolac
TABLET, EXTENDED RELEASE;ORAL020584-002Oct 25, 1996► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
Deloitte
Chubb
Citi
Teva
Mallinckrodt
US Department of Justice
Accenture
Express Scripts

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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