Lodine

NDA 18922, held by Wyeth Pharms Inc. Etodolac.

As of Nov 13, 2026, NDA 18922 (Lodine), held by Wyeth Pharms Inc, was first approved by FDA on Jan 31, 1991, with 22 approved supplements and 0 published complete response letters.

First approved: Jan 31, 1991
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jun 28, 1996	Supplement 13Efficacy (new indication or use) · Standard review	Approved	None posted
Jan 31, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Lodine200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Etodolac	DiscontinuedReference drug
Lodine300MG · capsule;oral	Etodolac	DiscontinuedReference drug
Lodine400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Etodolac	DiscontinuedReference drug
Lodine500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Etodolac	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 11, 2007	Supplement 23Labeling · Standard review	Approved	Label Letter
Jan 18, 2006	Supplement 22Labeling · Standard review	Approved	Letter Label
May 24, 2005	Supplement 21Labeling · Standard review	Approved	Label Letter
May 24, 2005	Supplement 20Labeling · Standard review	Approved	None posted
May 24, 2005	Supplement 19Labeling · Standard review	Approved	None posted
May 24, 2005	Supplement 18Labeling · Standard review	Approved	None posted
May 24, 2005	Supplement 17Labeling · Standard review	Approved	None posted
Dec 8, 1997	Supplement 16Manufacturing · Standard review	Approved	None posted
Jun 28, 1996	Supplement 15Labeling · Standard review	Approved	None posted
Jun 28, 1996	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 28, 1996	Supplement 13Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 8, 1994	Supplement 12Labeling · Standard review	Approved	None posted
Dec 8, 1994	Supplement 10Labeling · Standard review	Approved	None posted
Jul 29, 1993	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 29, 1993	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 19, 1993	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 12, 1993	Supplement 6Labeling	Approved	None posted
Jan 12, 1993	Supplement 5Manufacturing · Standard review	Approved	Review
Oct 28, 1992	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 11, 1992	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 25, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 4, 1991	Supplement 3Labeling	Approved	None posted
Jan 31, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 18922
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