Details for New Drug Application (NDA): 090547

NDA 090547 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Hainan Poly, Novel Labs Inc, Rising, Almaject, Aspiro, Eugia Pharma, Gland Pharma Ltd, Meitheal, Norvium Bioscience, Sandoz Inc, Slate Run Pharma, UBI, Xellia Pharms Aps, 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-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 090547

Tradename:	VORICONAZOLE
Applicant:	Mylan Pharms Inc
Ingredient:	voriconazole
Patents:	0

Pharmacology for NDA: 090547

Mechanism of Action

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

Medical Subject Heading (MeSH) Categories for 090547

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

Suppliers and Packaging for NDA: 090547

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VORICONAZOLE	voriconazole	TABLET;ORAL	090547	ANDA	Mylan Pharmaceuticals Inc.	0378-1626	0378-1626-93	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1626-93)
VORICONAZOLE	voriconazole	TABLET;ORAL	090547	ANDA	Mylan Pharmaceuticals Inc.	0378-1640	0378-1640-93	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1640-93)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Apr 22, 2010	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Apr 22, 2010	TE:	AB	RLD:	No

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