← FDA DRUG APPROVALS

FDA NDA · NDA022003

NOXAFIL

posaconazole

Sponsor: SCHERING

APPLICATION
NDA022003
TYPE
NDA
ORIGINAL APPROVAL
2006-09-15
LATEST ACTION
2026-01-27
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

NOXAFIL · ReferencePrescription
POSACONAZOLE 40MG/ML · SUSPENSION · ORAL

Approval history

2026-01-27Efficacy · Supplement 34 · standard — Letter ↗AP
2024-10-25Labeling · Supplement 33 · standard — Label ↗AP
2022-01-20Labeling · Supplement 27 · standard — Label ↗AP
2022-01-13Labeling · Supplement 28 · standard — Label ↗AP
2022-01-03Labeling · Supplement 30 · standard — Letter ↗AP
2020-09-16Labeling · Supplement 26 · standard — Letter ↗AP
2019-03-11Labeling · Supplement 24 · standard — Letter ↗AP
2019-02-21Labeling · Supplement 25 · standard — Letter ↗AP
2018-01-04Labeling · Supplement 22 · standard — Letter ↗AP
2016-09-09Labeling · Supplement 21 · standard — Letter ↗AP
2016-04-11Manufacturing (CMC) · Supplement 19 · priorityAP
2015-11-13Labeling · Supplement 18 · standard — Label ↗AP
2015-11-13Labeling · Supplement 20 · standard — Label ↗AP
2015-08-13Manufacturing (CMC) · Supplement 17 · priorityAP
2015-07-14Labeling · Supplement 16 · standard — Label ↗AP
2015-06-15Manufacturing (CMC) · Supplement 15 · priorityAP
2014-06-16Manufacturing (CMC) · Supplement 14 · priorityAP
2014-01-07Manufacturing (CMC) · Supplement 13 · priorityAP
2012-06-21Labeling · Supplement 12 · standard — Letter ↗AP
2012-06-21Labeling · Supplement 11 · standard — Letter ↗AP
2010-09-08Labeling · Supplement 8 · standard — Label ↗AP
2009-02-19Labeling · Supplement 7 · standard — Label ↗AP
2008-05-20Labeling · Supplement 6 · standard — Letter ↗AP
2008-05-20Labeling · Supplement 2 · standard — Letter ↗AP
2006-09-15Type 1 - New Molecular Entity · Original · priority — 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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