Details for New Drug Application (NDA): 208562

NDA 208562 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Hainan Poly, Novel Labs Inc, Rising, Almaject, Aspiro, Chartwell Rx, Eugia Pharma, Gland Pharma Ltd, Meitheal, Norvium Bioscience, Sandoz Inc, Slate Run Pharma, UBI, Zydus Pharms, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Cadila, 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-four 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-six suppliers are listed for this compound. Additional details are available on the voriconazole profile page.

Summary for 208562

Tradename:	VORICONAZOLE
Applicant:	Chartwell Rx
Ingredient:	voriconazole
Patents:	0

Pharmacology for NDA: 208562

Mechanism of Action

Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A4 Inhibitors

Medical Subject Heading (MeSH) Categories for 208562

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

Suppliers and Packaging for NDA: 208562

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VORICONAZOLE	voriconazole	INJECTABLE;INTRAVENOUS	208562	NDA	XGen Pharmaceuticals DJB, Inc.	39822-1077	39822-1077-1	1 VIAL, SINGLE-DOSE in 1 CARTON (39822-1077-1) / 20 mL in 1 VIAL, SINGLE-DOSE
VORICONAZOLE	voriconazole	INJECTABLE;INTRAVENOUS	208562	NDA	Xellia Pharmaceuticals USA LLC	70594-067	70594-067-01	1 VIAL, SINGLE-DOSE in 1 CARTON (70594-067-01) / 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	200MG/VIAL
Approval Date:	Mar 9, 2017	TE:	AP	RLD:	No

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