Details for New Drug Application (NDA): 090862

NDA 090862 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, Hainan Poly Pharm, 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-eight NDAs. It is available from thirty-one 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-two suppliers are listed for this compound. Additional details are available on the voriconazole profile page.

Summary for 090862

Tradename:	VORICONAZOLE
Applicant:	Sandoz Inc
Ingredient:	voriconazole
Patents:	0

Pharmacology for NDA: 090862

Mechanism of Action

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

Medical Subject Heading (MeSH) Categories for 090862

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

Suppliers and Packaging for NDA: 090862

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VORICONAZOLE	voriconazole	POWDER;INTRAVENOUS	090862	ANDA	Sandoz Inc	0781-3416	0781-3416-94	1 VIAL, SINGLE-USE in 1 CARTON (0781-3416-94) / 20 mL in 1 VIAL, SINGLE-USE
VORICONAZOLE	voriconazole	POWDER;INTRAVENOUS	090862	ANDA	Civica, Inc.	72572-875	72572-875-01	1 VIAL, SINGLE-USE in 1 CARTON (72572-875-01) / 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	200MG/VIAL
Approval Date:	May 30, 2012	TE:	AP	RLD:	No

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