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FDA NDA · NDA211210

QMIIZ ODT

Sponsor: TERSERA

APPLICATION
NDA211210
TYPE
NDA
ORIGINAL APPROVAL
2018-10-19
LATEST ACTION
2021-04-28
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

QMIIZ ODT · ReferenceDiscontinued
MELOXICAM 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
QMIIZ ODT · ReferenceDiscontinued
MELOXICAM 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2021-04-28Labeling · Supplement 2 · standard — Letter ↗AP
2019-08-20Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2018-10-19Type 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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