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Last Updated: April 24, 2025

Details for New Drug Application (NDA): 206398

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NDA 206398 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Hainan Poly, Novel Labs Inc, Rising, Almaject, Aspiro, Eugia Pharma, Gland Pharma Ltd, Hikma, Meitheal, Norvium Bioscience, Sandoz Inc, Slate Run Pharma, UBI, Zydus Pharms, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Cadila, Chartwell Rx, Epic Pharma Llc, Glenmark Pharms Ltd, Mylan Pharms Inc, Prinston Inc, and Teva Pharms, and is included in twenty-six NDAs. It is available from thirty-two suppliers. Additional details are available on the VORICONAZOLE profile page.

The generic ingredient in VORICONAZOLE is voriconazole. There are fourteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the voriconazole profile page.

Summary for 206398

Tradename:	VORICONAZOLE
Applicant:	Almaject
Ingredient:	voriconazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 206398

14-alpha Demethylase Inhibitors
Antifungal Agents
Cytochrome P-450 CYP3A Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	200MG/VIAL
Approval Date:	Mar 23, 2016	TE:	AP	RLD:	No

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