← FDA DRUG APPROVALS

FDA NDA · NDA020584

LODINE XL

Sponsor: WYETH PHARMS INC

APPLICATION
NDA020584
TYPE
NDA
ORIGINAL APPROVAL
1996-10-25
LATEST ACTION
2006-01-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

LODINE XLDiscontinued
ETODOLAC 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
LODINE XLDiscontinued
ETODOLAC 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
LODINE XL · ReferenceDiscontinued
ETODOLAC 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2006-01-18Labeling · Supplement 9 · standard — Letter ↗AP
2005-05-25Labeling · Supplement 7 · standard — Label ↗AP
2005-05-25Labeling · Supplement 6 · standard — Letter ↗AP
2005-05-25Labeling · Supplement 4 · standard — Letter ↗AP
2000-08-11Efficacy · Supplement 5 · unknown — Label ↗AP
1999-05-27Efficacy · Supplement 3 · standard — Review ↗AP
1998-02-03Labeling · Supplement 1 · standard — Review ↗AP
1998-01-23Manufacturing (CMC) · Supplement 2 · standardAP
1996-10-25Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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