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Last Updated: November 2, 2024

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-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the etodolac profile page.
Summary for 020584
Tradename:LODINE XL
Applicant:Wyeth Pharms Inc
Ingredient:etodolac
Patents:0
Medical Subject Heading (MeSH) Categories for 020584

Profile 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EXTENDED RELEASE;ORALStrength400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 25, 1996TE:RLD:No

Profile 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EXTENDED RELEASE;ORALStrength600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 25, 1996TE:RLD:Yes

Profile 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EXTENDED RELEASE;ORALStrength500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jan 20, 1998TE:RLD:No

Expired US 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;ORAL 020584-001 Oct 25, 1996 ⤷  Sign Up ⤷  Sign Up
Wyeth Pharms Inc LODINE XL etodolac TABLET, EXTENDED RELEASE;ORAL 020584-002 Oct 25, 1996 ⤷  Sign Up ⤷  Sign Up
Wyeth Pharms Inc LODINE XL etodolac TABLET, EXTENDED RELEASE;ORAL 020584-003 Jan 20, 1998 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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