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FDA NDA · NDA021497

ALINIA

Sponsor: ROMARK

APPLICATION
NDA021497
TYPE
NDA
ORIGINAL APPROVAL
2004-07-21
LATEST ACTION
2022-01-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ALINIA · ReferenceDiscontinued
NITAZOXANIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2022-01-19Labeling · Supplement 18 · standard — Label ↗AP
2021-12-16Labeling · Supplement 17 · standard — Label ↗AP
2016-07-11Labeling · Supplement 1 · standard — Label ↗AP
2015-03-03Manufacturing (CMC) · Supplement 4 · priorityAP
2012-12-05Manufacturing (CMC) · Supplement 3 · priorityAP
2004-07-21Type 3 - New Dosage Form · Original · priority — Review ↗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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