← FDA DRUG APPROVALS

FDA NDA · NDA205053

NOXAFIL

posaconazole

Sponsor: MERCK SHARP DOHME

APPLICATION
NDA205053
TYPE
NDA
ORIGINAL APPROVAL
2013-11-25
LATEST ACTION
2026-01-27
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

NOXAFIL · ReferenceDiscontinued
POSACONAZOLE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, DELAYED RELEASE · ORAL

Approval history

2026-01-27Efficacy · Supplement 18 · standard — Letter ↗AP
2024-10-25Labeling · Supplement 17 · standard — Label ↗AP
2022-01-20Labeling · Supplement 13 · standard — Label ↗AP
2022-01-13Labeling · Supplement 14 · standard — Label ↗AP
2021-06-17Efficacy · Supplement 11 · standard — Letter ↗AP
2021-05-31Efficacy · Supplement 12 · standard — Label ↗AP
2020-09-16Labeling · Supplement 10 · standard — Letter ↗AP
2019-03-11Labeling · Supplement 8 · standard — Letter ↗AP
2019-02-21Labeling · Supplement 9 · standard — Letter ↗AP
2018-01-04Labeling · Supplement 6 · standard — Letter ↗AP
2016-09-09Labeling · Supplement 5 · standard — Letter ↗AP
2015-11-13Labeling · Supplement 4 · standard — Label ↗AP
2015-11-13Labeling · Supplement 2 · standard — Label ↗AP
2014-06-11Labeling · Supplement 1 · standard — Label ↗AP
2013-11-25Type 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →