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FDA NDA · NDA207233

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APPLICATION
NDA207233
TYPE
NDA
ORIGINAL APPROVAL
2015-10-22
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

VIVLODEX · ReferenceDiscontinued
MELOXICAM 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
VIVLODEX · ReferenceDiscontinued
MELOXICAM 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2024-11-21Labeling · Supplement 5 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 4 · standard — Letter ↗AP
2016-05-17Manufacturing (CMC) · Supplement 1 · standardAP
2015-10-22Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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