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FDA NDA · NDA018922

LODINE

Sponsor: WYETH PHARMS INC

APPLICATION
NDA018922
TYPE
NDA
ORIGINAL APPROVAL
1991-01-31
LATEST ACTION
2007-10-11
ROUTE
ORAL
DOSAGE FORM
TABLET, CAPSULE
MARKETING STATUS
Discontinued

Products

LODINE · ReferenceDiscontinued
ETODOLAC 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LODINE · ReferenceDiscontinued
ETODOLAC 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
LODINE · ReferenceDiscontinued
ETODOLAC 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LODINE · ReferenceDiscontinued
ETODOLAC 300MG · CAPSULE · ORAL

Approval history

2007-10-11Labeling · Supplement 23 · standard — Letter ↗AP
2006-01-18Labeling · Supplement 22 · standard — Letter ↗AP
2005-05-24Labeling · Supplement 18 · standardAP
2005-05-24Labeling · Supplement 20 · standardAP
2005-05-24Labeling · Supplement 19 · standardAP
2005-05-24Labeling · Supplement 17 · standardAP
2005-05-24Labeling · Supplement 21 · standard — Label ↗AP
1997-12-08Manufacturing (CMC) · Supplement 16 · standardAP
1996-06-28Manufacturing (CMC) · Supplement 14 · standardAP
1996-06-28Labeling · Supplement 15 · standardAP
1996-06-28Efficacy · Supplement 13 · standardAP
1994-12-08Labeling · Supplement 12 · standardAP
1994-12-08Labeling · Supplement 10 · standardAP
1993-07-29Manufacturing (CMC) · Supplement 7 · standardAP
1993-07-29Manufacturing (CMC) · Supplement 8 · standardAP
1993-03-19Manufacturing (CMC) · Supplement 9 · standardAP
1993-01-12Manufacturing (CMC) · Supplement 5 · standard — Review ↗AP
1993-01-12Labeling · Supplement 6AP
1992-10-28Manufacturing (CMC) · Supplement 2 · standardAP
1992-02-11Manufacturing (CMC) · Supplement 1 · standardAP
1991-11-25Manufacturing (CMC) · Supplement 4 · standardAP
1991-10-04Labeling · Supplement 3AP
1991-01-31Type 1 - New Molecular Entity · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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