Lodine Xl

NDA 20584, held by Wyeth Pharms Inc. Etodolac.

As of Nov 13, 2026, NDA 20584 (Lodine Xl), held by Wyeth Pharms Inc, was first approved by FDA on Oct 25, 1996, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 25, 1996
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Aug 11, 2000	Supplement 5Efficacy (new indication or use)	Approved	Review Label Letter
May 27, 1999	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Oct 25, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Lodine Xl400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Etodolac	Discontinued
Lodine Xl600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Etodolac	DiscontinuedReference drug
Lodine Xl500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Etodolac	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Jan 18, 2006	Supplement 9Labeling · Standard review	Approved	Letter Label
May 25, 2005	Supplement 4Labeling · Standard review	Approved	Letter Label
May 25, 2005	Supplement 6Labeling · Standard review	Approved	Letter Label
May 25, 2005	Supplement 7Labeling · Standard review	Approved	Label Letter
Aug 11, 2000	Supplement 5Efficacy (new indication or use)	Approved	Review Label Letter
May 27, 1999	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Feb 3, 1998	Supplement 1Labeling · Standard review	Approved	Review
Jan 23, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 25, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20584
Drugs@FDA: Overview at FDA
Company: Wyeth Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters