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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 205034

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NDA 205034 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Hetero Labs Ltd V, Novel Labs Inc, Rising, Zhejiang Poly Pharm, Almaject, Aspiro, Eugia Pharma, Gland, Hikma, Meitheal, Pharmobedient, 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-seven NDAs. It is available from thirty 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-one suppliers are listed for this compound. Additional details are available on the voriconazole profile page.

Summary for 205034

Tradename:	VORICONAZOLE
Applicant:	Amneal Pharms
Ingredient:	voriconazole
Patents:	0

Pharmacology for NDA: 205034

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A4 Inhibitors

Medical Subject Heading (MeSH) Categories for 205034

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

Suppliers and Packaging for NDA: 205034

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VORICONAZOLE	voriconazole	FOR SUSPENSION;ORAL	205034	ANDA	Amneal Pharmaceuticals LLC	65162-913	65162-913-22	75 mL in 1 BOTTLE (65162-913-22)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	200MG/5ML
Approval Date:	Apr 13, 2016	TE:	AB	RLD:	No

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