← FDA DRUG APPROVALS

FDA NDA · NDA020938

MOBIC

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA020938
TYPE
NDA
ORIGINAL APPROVAL
2000-04-13
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MOBIC · ReferenceDiscontinued
MELOXICAM 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MOBIC · ReferenceDiscontinued
MELOXICAM 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2024-11-21Labeling · Supplement 30 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 28 · standard — Letter ↗AP
2016-06-30Labeling · Supplement 26 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 25 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 24 · standard — Label ↗AP
2012-03-05Labeling · Supplement 22 · unknown — Letter ↗AP
2011-08-03Labeling · Supplement 21 · standard — Letter ↗AP
2010-07-29Labeling · Supplement 20 · unknown — Label ↗AP
2010-04-26Labeling · Supplement 19 · standard — Label ↗AP
2008-06-27Labeling · Supplement 18 · standard — Letter ↗AP
2007-01-25Labeling · Supplement 17 · standard — Letter ↗AP
2005-08-11Labeling · Supplement 15 · standard — Label ↗AP
2005-08-11Efficacy · Supplement 13 · priority — Letter ↗AP
2004-07-16Efficacy · Supplement 4 · standard — Letter ↗AP
2003-04-28Labeling · Supplement 7 · standard — Label ↗AP
2002-12-13Manufacturing (CMC) · Supplement 9 · standardAP
2002-11-21Manufacturing (CMC) · Supplement 8 · standardAP
2002-06-10Manufacturing (CMC) · Supplement 6 · standardAP
2002-01-10Manufacturing (CMC) · Supplement 5 · standardAP
2000-12-15Manufacturing (CMC) · Supplement 3 · standardAP
2000-11-14Manufacturing (CMC) · Supplement 2 · standardAP
2000-08-23Manufacturing (CMC) · Supplement 1 · standardAP
2000-04-13Type 1 - New Molecular Entity · Original · standard — Label ↗AP
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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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