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FDA NDA · NDA022027

NOXAFIL

Sponsor: SCHERING

APPLICATION
NDA022027
TYPE
NDA
ORIGINAL APPROVAL
2006-10-20
LATEST ACTION
2012-06-21
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

NOXAFILPrescription
POSACONAZOLE 40MG/ML · SUSPENSION · ORAL

Approval history

2012-06-21Labeling · Supplement 2 · standard — Label ↗AP
2012-06-21Labeling · Supplement 3 · unknown — Label ↗AP
2010-09-08Labeling · Supplement 1 · standard — Letter ↗AP
2006-10-20Type 6 - New Indication (no longer used) · Original · unknown — 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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