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FDA NDA · NDA021498

ALINIA

Sponsor: ROMARK

APPLICATION
NDA021498
TYPE
NDA
ORIGINAL APPROVAL
2002-11-22
LATEST ACTION
2022-01-19
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

ALINIA · ReferenceDiscontinued
NITAZOXANIDE 100MG/5ML · FOR SUSPENSION · ORAL

Approval history

2022-01-19Labeling · Supplement 19 · standard — Label ↗AP
2016-07-11Labeling · Supplement 4 · standard — Letter ↗AP
2014-09-29Manufacturing (CMC) · Supplement 7 · priorityAP
2014-07-25Manufacturing (CMC) · Supplement 6 · priorityAP
2005-06-16Efficacy · Supplement 3 · priority — Letter ↗AP
2004-07-21Supplement · Supplement 1 · priority — Label ↗AP
2004-07-21Efficacy · Supplement 2 · unknownAP
2002-11-22Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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